PCMT Reports

Requirements Specification
STATUS APPROVED DATE
DOCUMENT NO.
RS-000885
VERSION NO. PAGE NO.
For Review
TITLE
3.4
1 of 155
Product Complaints Metrics & Trending (PCMT) - Requirements Specification
Product Complaints Metrics and Trending (PCMT) System Requirements Specification System Number ASN02993
For Review
CONFIDENTIALITY STATEMENT Information and data contained herein are proprietary and confidential.
This information should not be disclosed to any third party without the prior written consent of Amgen Incorporated.
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
2 of 155
Revision History
Version 1.0 Changes Initial version Added text prior to the Appendices explaining the folder structure of the reports in BusinessObjects Made the following changes in response to defects noted during the execution of OQ execution (OQ-006616 (pre-approval) / OQ-006754 (post-approval)): o Updated Appendix B PC Initiated Rate Report Added column Product Reported Name to section B2.1A. (defect # 2261) Updated Appendix E Open vs. Overdue Report: Removed reference to a hyperlink in the Total and Count fields in section E2.1. (defect # 2303) Updated Appendix H Site Partner Report: Removed duplicate column for Assessor Site in section H1A. (defect # 2302) Removed reference to a hyperlink in the Amgen Assessment Site in section H1B. (defect # 2300) Updated Appendix I Excursion Report: In section I3, changed Red Bold text to Above Baseline Rate. (defect # 2279) In section I4, added Ascending sort order to Baseline Rate column. (defect # 2281) Updated Appendix M Assessment Drill Report: Modified Universe Class / Object or Variable Derived Rule entry for column Date Ackn by Ext Assessor (defect # 2223) RFC034859 Janet Larson RFC Number RFC034859 Compiled by Michael Lombard
For Review
o 2.0
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
3 of 155
Version
Changes Updated Appendix H Site Partner Report: Removed hyperlink from NonAmgen Assessment Site (section H1D Pivot Table # 2) Updated Appendix A - Product Complaint Closure Performance Cycle Time 45 days: Added column Complaint Due Month (45 Days) in report fields (Section A1.1) Addition of Hyperlink in count column of report. Section A1.7: Added a table in performance requirements Section A1.10: Addition of the following variables: # of PCs Closed OnTime (30 Days) % of PCs Closed OnTime (30 Days) # of PCs Closed OnTime (45 Days) % of PCs Closed OnTime (45 Days) o 30 days: A2.1: Report fields: Added column Complaint Due Month (30 Days) Addition of Hyperlink in count column of report. Section A1.7: Added a table in performance requirements Section A2.10 Added variables: # of PCs Closed OnTime (30 Days) % of PCs Closed OnTime (30 Days) # of PCs Closed OnTime (45 Days) % of PCs Closed OnTime (45 Days) Updated Appendix B - Product Complaint Initiated Rate Report B2.1A Report Fields Graph Added columns: Complaint Initiated Year and Complaint Initiated Quarter B2.1B Report Fields Cross Tab Hyperlink for Number Of Records column o
RFC Number RFC039328
Compiled by
3.0
Janet Larson
For Review
RFC10270
Devika Yeravdekar
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
4 of 155
Version
Changes has been updated. B3.1B Report Fields Cross Tab: Hyperlink for Number Of Records column has been updated by Sreen. B1.1 Report Fields - Hyperlink for Number Of Records column has been updated by Sreen. Updated Appendix C - Right First Time Report C1.1: Added hyperlink to format row in initial 6 columns Hyperlink added to variable TotalCompsForATO and TotalCompsForELC C2.2: Changed operator for investigation site and Investigation Level from Equal To to In List C2.10: removed variable vInvestLevelPrompt and added variables level and NewLevel o Updated Appendix D: Interim Report Adherence Report D1: Added column Interim Report on Time? D2: Removed prompts D3: added comments column. Changed filter conditions: Changes to AND Removed AND( Removed OR ) Added column/filter names: Past Due As of Report Date, Complaint Status, Unique Identifier D4: Added alerter: AlerterDisplayBlankAssmntNumberCurrentStatu sAssmtType D10: Report Variables Design Added variables: Removed Interim Report Past Due ? As it no more exists in Sreens excel sheet. o
RFC Number
Compiled by
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
5 of 155
Version
Changes Added Prior Cycle End Date, Prior Cycle Start Date and DueDate. Changed purpose of Past Due As Of Report Date, vEsignOnTime and Days Past Due As Of Report Date and Interim Report On Time?. Updated Appendix E - Open vs. Overdue Complaints Report E1.1A Report Fields Vertical Stack Graph # 2: Added Interactive Report Filters Yes for IO Site column E1.1B Cross Tab # 2 Removed hyperlink from IO Site column, format row E1.3 Added Notes for Complaint Type E1.10 Report Variables Design Added variable Site E2.1 Report fields Added hyperlink in Total Column and Count Row columns. E2.3: added notes column. E2.10: added variables: Site, Total and Count o Updated Appendix F - Overall Product Complaint/Issues Rates Report CiPM tab: F2.1C Report Fields Line Graph # 2 Changed Complaint Initiated Month columns Format row to Drill up/down instead of hyperlink F2.1B Report Fields Cross Tab # 2 Changed Complaint Initiated Month columns Format row to Drill up/down instead of hyperlink F2.1E Report Fields Line Graph # 3 Changed Complaint Initiated Month columns Format row to Drill up/down instead of hyperlink o
RFC Number
Compiled by
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
6 of 155
Version
Changes
RFC Number
Compiled by
Updated Appendix G - Top Product Complaint Cause Codes by Product Report G1.1A Report Fields Line Graph Removed Yes from interactive report filters row for Complaint Initiated Month/Quarter/Year Added column IOSite G1.1B Report Fields Vertical Table Added column Product Name And changed name of section from vertical tab to cross tab G1.2 Prompts Changes to 3 existing descriptions names and addition of 2 more rows. G1.3 Filter Conditions Changed Rank Removed rest Added Production Volume Measure, Cause Code, IO Site, Region, IO Site, Region, IO Site. G1.10 Report Variables Design Added Complaint Initiated Date, Ranking Period Link Variable G2.1 Report Fields Removed column Distribution Quantity Month Added column Complaint Initiated Date (CiPM Month/CiPM Quarter/CiPM Year) G2.2 Prompts Changes to 3 existing descriptions names and their operators and type and addition of 2 more rows. Also added comments column. G2.3 Filter Conditions Changed Rank: operator, value, universe object/filter and removed comments Added Production Volume Measure, Cause Code, IO Site, Region, IO Site, Region, IO Site. G2.10 Report Variables Design Added Complaint Initiated Date variable. o
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
7 of 155
Version
Changes
RFC Number
Compiled by
Updated Appendix H - Site/Partner Performance in Complaint Assessments Management H5 Drill Up / Drill Down and Links Added comments column. NONE other? o Updated Appendix I - Periodic Product Complaint Excursion Report I1.1 Report Fields Header - Changed last column. Table - Issues Concatenated renamed as Product - Item Type - Cause Code Removed Complaint Initiated Month and added CiPM Month I1.2 Prompts Added description column for CiPM Month I1.3 Filter Conditions Added row: baseline Removed rows: record type and complaint type Changed universe object of Baseline Measure and added comments here I1.4 Alerts and Conditional Formatting Added Baseline Rate and CiPM Null I1.10 Report Variables Design Added: CiPM End, CiPM Start, Distribution, Issue Count, Period 2, Period 4, Period 6, Period 7, Period 8 Changed: Max Baseline Removed 1 Sigma Indicator o I2 Summary Report Tab # 2 Trending Working Presentation Tab name changed to: TrendingWorkingPresentationByGroup I2.1 Report Fields Header: Updated last column Table:
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
8 of 155
Version
Changes Added column Product - Item Type Cause Code Removed Complaint Initiated Month and added CiPM Month Added Totals 1 Sig, 2 Sig, 3 Sig Added section I2.1.1: CrossTab2 Sigma Violations Added section I2.1.2: CrossTab1 Sigma Violations Added section I2.1.3: CrossTab 9 Consecutive Below Baseline I2.2 Prompts Added description column (CiPM Month) Combined rows 1 and 2 for operator Changed applies to column in both rows I2.3 Filter Conditions Renamed section to I2.3 Filter Conditions 3 Sigma Violations Removed Record Type And complaint Type rows and added Baseline and 3 sigma total. Changed universe object for baseline measure to Measures/CiPM Measures/Baseline Measure Changed comments column of all rows to This is a Pre-set Filter and This is a block filter Added section I2.3.2 Filter Conditions 2 Sigma Violations Added section I2.3.3 Filter Conditions 1 Sigma Violations Added section I2.3.3 Filter Conditions 9 Consecutive Below Baseline I2.4 Alerts and Conditional Formatting Added 4 new alerters viz. 1 Sigma total, 2 Sigma total, 3 Sigma total, Baseline Total Changed description in section I2.8 Print Requirements I2.10 Report Variables Design Added: CiPM End, CiPM Start, Distribution, Issue Count, Period 2, Period 4, Period 6, Period 7, Period 8 Changed: Max Baseline
RFC Number
Compiled by
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
9 of 155
Version
Changes Removed 1 Sigma Indicator I3 Summary Report Tab # 3 Risk Baseline Rate Analysis I3.1 Report Fields Header Updated last column. Table: Issues Concatenated renamed as Product - Item Type - Cause Code Removed Complaint Initiated Month and added CiPM Month I3.2 Prompts Added description column Combined both operator rows. Changed Applies To for both rows. I3.3 Filter Conditions Removed Record Type and Complaint Type rows and added Baseline Changed operator, Universe Object/Filter and value for Baseline Measure. I3.10 Report Variables Design Added: CiPM End, CiPM Start, Distribution, Issue Count, Period 2, Period 4, Period 6, Period 7, Period 8 Changed: Max Baseline Removed 1 Sigma Indicator I4 Summary Report Tab # 4 Risk Baseline Rate Excursions I4.1 Report Fields Header Changed last column Table: Removed Complaint Initiated Month and added CiPM Month I4.2 Prompts Added description column Combined both operator rows. Changed Applies To for both rows. I4.3 Filter Conditions Removed Record Type and Complaint Type rows Baseline Measure
RFC Number
Compiled by
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
10 of 155
Version
Changes Added 2 rows of Baseline Rate Total I4.10 Report Variables Design Added: CiPM End, CiPM Start, Distribution, Issue Count, Period 2, Period 4, Period 6, Period 7, Period 8 Changed: Max Baseline Removed 1 Sigma Indicator I5 Summary Report Tab # 5 Trending Charts I5.1 Report Fields Removed Complaint Initiated Month and added CiPM Month. I5.2 Prompts Added description column Merged operator rows Changed applies to for both rows I5.3 Filter Conditions Removed record Type and Complaint Type rows Added rows Baseline and Baseline Measure I5.10 Report Variables Design Added Baseline Rate Violation, CiPM End, CiPM Start, 1 Sigma Total, 1 Sigma Violation, 2 Sigma Total, 2 Sigma Violation, 3 Sigma Total, 3 Sigma Violation, Baseline Rate Total, Baseline Rate Violation, Baseline Total (9 Below), Below Baseline, Distribution, Issue Count, Max Baseline, Period 1, Period 1 Month, Period 1 Year, Period 2, Period 3, Period 4, Period 5, Period 6, Period 7, Period 8, Period 9 Updated Appendix J - Complaint Issues With Failure Identified J5 Drill Up / Drill Down and Links Drill/link name of Complaint Drill report and issues drill report was changed to Complaint No. and Issues No. and changed links for these 2. Included link in description of Link To o
RFC Number
Compiled by
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
11 of 155
Version
Changes BTRS Updated Appendix K - Drill Table Complaint K2 Prompts Addition of 10 prompts o Updated Appendix L - Drill Table Issue L1 Report Fields Added column Manufactured By L2 Prompts Added 7 prompts: 19 through 26 o Updated Appendix M - Drill Table Assessment M1 Report Fields Added column Manufactured By M2 Prompts Added prompts 18 through 24 o
RFC Number
Compiled by
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
12 of 155
Table of Contents
1. Introduction ...............................................................................................................14 Purpose & Scope ........................................................................................................14 Definitions and Abbreviations ......................................................................................15 Related Documents.....................................................................................................16 Exclusions...................................................................................................................16 2. System Overview ......................................................................................................17 2.1 Process Context..........................................................................................................17 2.2 Description ..................................................................................................................18 3. Functional Requirements .........................................................................................20 3.1 Not Applicable.............................................................................................................20 4. Supplementary Requirements..................................................................................21 4.1 Data Requirements .....................................................................................................21 4.2 Universe Requirements...............................................................................................22 4.3 Reporting Requirements .............................................................................................22 4.4 Access Control............................................................................................................29 4.5 System-wide Business Rules ......................................................................................30 5. Non-Functional Requirements .................................................................................31 5.1 Usability ......................................................................................................................31 5.2 Dependability ..............................................................................................................31 5.3 Security.......................................................................................................................31 5.4 Performance ...............................................................................................................32 5.5 Traceability..................................................................................................................32 5.6 Historical Data Requirements......................................................................................33 5.7 Data Completeness and Accuracy Requirements .......................................................33 5.8 Data Reconciliation Requirements ..............................................................................33 5.9 System Availability Requirements ...............................................................................33 5.10Report and Query Performance Requirements ...........................................................34 6. Procedural Requirements.........................................................................................35 6.1 Applicable Regulations................................................................................................35 6.2 Procedural Controls ....................................................................................................35 6.3 Business Continuity / Service Level Agreements.........................................................39 6.4 Support .......................................................................................................................39 6.5 Training Procedures....................................................................................................39 A. APPENDIX A - Product Complaint Closure Performance Cycle Time Report Report Specification................................................................................................41 B. APPENDIX B - Product Complaint Initiated Rate Report Report Specification ...........................................................................................................................48 C. APPENDIX C - Right First Time Report Report Specification .............................58 D. APPENDIX D - Interim Report Adherence Report Report Specification .............67 E. APPENDIX E - Open vs. Overdue Complaints Report Report Specification ...........................................................................................................................72 F. APPENDIX F - Overall Product Complaint/Issues Rates Report Report Specification ...........................................................................................................................79 1.1 1.2 1.3 1.4
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
13 of 155
G. APPENDIX G - Top Product Complaint Cause Codes by Product Report Report Specification ...............................................................................................................90 H. APPENDIX H - Site/Partner Performance in Complaint Assessments Management Report Report Specification .........................................................................99 I. APPENDIX I - Periodic Product Complaint Excursion Report Report Specification .........................................................................................................................105 J. APPENDIX J - Complaint Issues With Failure Identified Report Report Specification .........................................................................................................................134 K. APPENDIX K - Drill Table Complaint Report Specification ............................138 L. APPENDIX L - Drill Table Issue Report Specification .....................................144 M. APPENDIX M - Drill Table Assessment Report Specification.........................150
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
14 of 155
1. Introduction
1.1 Purpose & Scope
This document articulates the business and system requirements for the Product Complaint Metrics and Trending (PCMT) system. Because this is a reporting system only, the majority of the business and system requirements are documented in Section 4 Supplementary Requirements of this document, with the other system contextual requirements (non-functional) documented in other sections. All these requirements represent a complete and comprehensive description of the system. PCMT provides the means to standardize and automate the creation of reports used by the Quality Department to satisfy various departmental reporting requirements. A new data mart will be established to support the reporting requirements. The data mart will be populated from two sources as identified in Table 1 PCMT Data Requirements below.
For Review
Source
PCMT Data Requirements Product Complaint, Safety Investigation, Consolidated Investigation, Product Security Investigation and Trend Investigation (CMIS record type data) and support data (CMIS dimensions)
CMIS
Product distribution and return data and the Baseline data used for monthly Spreadsheets trending Table 1 PCMT Data Requirements
The subject areas included in the scope of PCMT includes complaints, issues and assessments. PCMT will use product complaints data and will deliver reporting and analysis capabilities for the following analytical areas: Inspection and Audit Readiness Product and Process Improvement Executive Management Reporting
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
15 of 155
1.2
1.2.1
Definitions and Abbreviations

Definitions Term Ad hoc query BusinessObjects Class B Definition The ability to peruse and analyze data in a database without using pre-created reports. The commercially available tool used to provide the reporting capabilities provided with PCMT. It is an Amgen standard too. Classification for the performance of the reports, as defined in the SLA. Dimension tables describe individual characteristics of the data in the data base. For example there would be dimension tables containing the names of all Amgen products, the names of all manufacturing and all Initiating Organization Sites, the names of valid complaint types, codes and the names for all issue and assessment types. Changing the view of the data to a greater level of detail. In the PCMT data mart, the central tables which contain the individual facts being stored. Level assigned to CMIS records where the issue does not require investigation Level assigned to CMIS records where the issue requires investigation to determine if a failure can be identified The business area around which the database is organized. A feature of BusinessObjects which presents the database to ad hoc users, using business terms rather than technical terms. It also contains pre-defined formulas for things such as Complaints Per Million (CPM) which ad hoc users can include in their analysis without having to recreate the formula each time it is used.
Dimension table
For Review
Drill down Fact table Investigation Level I (LI) Investigation Level II (LII) Subject Area
Universe
1.2.2
Abbreviations Abbreviation ABR CMIS EBI Meaning Amgen Breda Complaint Management Information System Enterprise Business Intelligence
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
16 of 155
Abbreviation EDW ETL GPSS IO LDAP PC PCMT PQS PSI SI TI
Meaning Enterprise Data Warehouse Extract, Transform, and Load Extract Transform Load as a role, refers to the Informatica interface application Global Product Safety Surveillance Investigating Organization Light Data Access Protocol Product Complaints Product Complaints Metrics and Trending Product Quality Surveillance Product Security Investigations Safety Investigations Trend Investigations
For Review
1.3
Related Documents
Document Title
Product Complaint Metrics And Trending (PCMT) System Design Specification Product Complaint Metrics And Trending (PCMT) System Compliance Assessment Product Complaint Metrics And Trending (PCMT) Validation Plan
Document Number
DS-000891 SCA-000329 VP-001306
1.4
Exclusions
Section
3.1 Use Cases 4.5 System-wide Business Rules
Reason
Not required for BI reporting All business rules are defined in the report, data, and universe specifications that are appendices in this document and the Design Specification DS-000891. All usability requirements are addressed in the report and universe specifications that are appendices in this document and the Design Specification DS-000891.
5.1 Usability
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
17 of 155
2. System Overview
Currently Product Quality Surveillance (PQS), supplemented by Amgen Breda QA (ABR QA) for ABR distributed products, use largely manual processes to produce trending and metrics reports, which are used for three purposes: Periodic executive management reporting Satisfying requests for information from auditors and inspectors As the first step in identifying trends in Investigation data which after investigation and resolution ultimately lead to product and process improvements
The solution described in this document will improve all three uses of Investigation information. Specifically it will: Reduce the time required to produce executive management reports by providing a set of standardized, Self Service reports designed to be used as the basis for management reporting. Provide site personnel the capability to respond directly to the majority of requests for information from auditors, inspectors and other site requests, thus significantly shorting the lag time between request and report, as well as relieving PQS and ABR QA of the task of satisfying the request. Provide PQS and ABR QA staff with tools to investigate anomalies in Investigation data and tools usable at the site level to assist site staff with root cause identification. This will lead to quicker, more accurate investigations and reduced product and process improvement cycles. Automation of what is currently a largely manual process will increase accuracy and repeatability and improve time to delivery in all three uses of the reports.
For Review
2.1
Process Context
The follow diagram provides a high-level overview of the Product Complaint Metrics and Trending (PCMT) environment.
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
18 of 155
For Review
2.2
Description
The transactional system, CMIS will act as the primary source system for the PCMT data mart. From this system will be pulled the following types of data: Complaint Records of the following types: o o o o o Consolidated investigations (CI) Product Complaints (PC) Safety Investigations (SI) Product Security Investigations (PSI) Trend Investigations (TI)
Issue records Assessment records Dimension data in support of the above information
Product distribution and returns data will be brought into the PCMT data mart from a manually maintained spreadsheet. Maintenance of this spreadsheet is not part of the PCMT solution. It is currently being
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
19 of 155
maintained manually, and will continue to be maintained manually outside of PCMT. A series of Self Service reports will be delivered with the system. These reports are detailed in Section 4.3 Reporting below. The Self Service reports will present information at the summary level and will enable users to drill-down to details following predefined drill-down paths. Two groups of users will have access to the system. Power Users will have access to all of the Self Service reports and will be authorized to use the full ad hoc suite of capabilities supplied with the reporting tool. Report Users will have access to all of the Self Service reports and will have drill-down capability where it is provided in the Self Service reports.
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
20 of 155
3. Functional Requirements
Use Cases are not used to describe functional requirements for a Business Intelligence solution. All functional requirements are described in Section 4 Supplementary Requirements. See Section 1.4 Exclusions above.
3.1
N/A
Not Applicable
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
21 of 155
4. Supplementary Requirements
Supplementary Requirements are organized into three sub-sections as follows: 4.1 Data Requirements 4.2 Universe Design Specifications 4.3 Reporting Requirements
4.1
Data Requirements
4.1.1 Transfer Data from Source System to Staging Area, which detail data movement from source systems to the PCMT staging area 4.1.2 Transfer Data from the Staging area to Data Core, which detail data movement from the staging area systems to the PCMT core tables 4.1.3 View Requirements, which detail the definition of all views supported within the PCMT Data Mart
Data Requirements are divided into three sub-sections:
For Review
Detailed descriptions of data transfer requirements, interface requirements and data core requirements can be found in the Product Complaint Metrics and Trending (PCMT) System Design Specification (DS000891). 4.1.1 Transfer Data from Source System to Staging Area
Transfer Data from Source System to Staging Area involves reading data from source system(s) and writing to tables in the Staging Area of PCMT. Tables in the Staging Area of the PCMT have the identical data structure as their source. No data transformation is performed on the source data during the transfer. Additional attributes may be added to the staging area table for administration purposes only. This process is of critical importance as it is the first step in moving data from the source to the PCMT data mart. The result of this data movement is to have source system data loaded into the PCMT Staging Area.
ID/ Number
4.1.1.1
Requirement Text
Data transfer from source to stage shall be mapped according to the data specifications documented in the Product Complaint Metrics And Trending (PCMT) System Design Specification (DS-000891)
4.1.2
Transfer Data from the Staging Area to Data Core
This section contains the functional requirements for the core data tables, which make up the PCMT data
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
22 of 155
mart. The details of the tables and mapping specified in this section can be found in the Product Complaint Metrics and Trending (PCMT) System Design Specification (DS-000891)
ID/ Number
4.1.2.1
Requirement Text
Data transfer from stage to core shall be mapped according to the data specifications documented in Product Complaint Metrics And Trending (PCMT) System Design Specification (DS-000891)
4.1.3
View Requirements
This section contains the functional requirements for views supported by the PCMT Data Mart.
For Review
ID/ Number
4.1.3.1
Requirement Text
Views shall be created according to the data specifications documented in the document Product Complaint Metrics And Trending (PCMT) System Design Specification (DS-000891)
4.2
Universe Requirements
The Universe is the access point to ad hoc use of the BusinessObjects tool. It defines the attributes available for use in ad hoc querying. It contains objects which are designed to aid business users. Objects in the Universe equate to every business related field in the PCMT data mart. In addition to objects relating to business fields, the Universe contains objects which define measures and other custom objects in support of business use.
ID/ Number
4.2.1
Requirement Text
The system shall have the ad hoc reporting capability for users.
4.3
Reporting Requirements
The following self-service reports shall be developed for PCMT:
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
23 of 155
4.3.1
Product Complaint Closure Performance Cycle Time
Report Description: This report tracks, in table format, by selected time period and IO sites, the following four metrics: On Time-Closed On Time-Open Over Due-Closed Over Due-Open
Report Purpose / Business Driver: The purpose of this report is to provide product complaint closure cycle times. This data shall be used to assist in the monitoring of complaint closure rates against targeted timelines.
ID/ Number
4.3.1.1
Requirement Text
The system shall contain a report called Product Complaint Closure Performance Cycle Time. See Appendix A - Product Complaint Closure Performance Cycle Time Report Specification for report requirements.
For Review
4.3.2
Product Complaint Initiated Rate:
Report Description: This report displays the percentage of complaints, by level, by time. These data are presented in the final data table, which breaks this information out by complaint type, record type, date and level. A third graph displays record types in a double y-axis graph showing both number of complaints and CPM by ATO/ELC. This graph is accompanied by a data table of the same information. Report Purpose / Business Driver: This report presents information about rates and investigation levels of initiated complaints. It is used to identify numbers of complaints and the ratio of complaints to staff assigned to them by site.
ID/ Number
4.3.2.1
Requirement Text
The system shall contain a report called Product Complaint Initiated Rate. See Appendix B Product Complaint Initiated Rate Report Report Specification for report requirements.
4.3.3
Right First Time Report
Report Description: This report provides a summary detailing the total number of closed PC records for Investigation Levels I
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
24 of 155
and II by IO Site and produces a list of closed complaints to be manually sampled. From this summary report, selecting active numbers from the summary will open detail lists of the items in summary. Report Purpose / Business Driver: The purpose of this report is to automate the process of closed complaint audit sampling. The data shall be used to audit the accuracy and completeness of complaint records which have been closed.
ID/ Number
4.3.3.1
Requirement Text
The system shall contain a report called Right First Time Report. See Appendix C Right First Time Report Report Specification for report requirements.
4.3.4
Interim Report Adherence:
For Review
Report Description: This report provides a table depicting the number of records by record type having an interim report on or before current target due date, along with other related information such as owner, status and number of days open. Report Purpose / Business Driver: This report documents the adherence to interim report creation. The data is used to monitor the assignment of interim report assessments to overdue records.
ID/ Number
4.3.4.1
Requirement Text
The system shall contain a report called Interim Report Adherence Report. See Appendix D Interim Report Adherence Report Report Specification for report requirements.
4.3.5
Open vs. Overdue Complaints:
Report Description: This report graphs on time versus overdue record types by IO Site and by those open greater than 45 days and greater than 90 days. Stacked bar, line graph and data tables are produced. Report Purpose / Business Driver: The purpose of this report is to show the numbers open and overdue complaints over time. The data will be used to identify closure trends.
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
25 of 155
ID/ Number
4.3.5.1
Requirement Text
The system shall contain a report called Open vs. Overdue Complaints. See Appendix E Open vs. Overdue Complaints Report Report Specification for report requirements.
4.3.6
Overall Product Complaint/Issues Rates
Report Description: This report provides two sets of graphs depicting the Product Complaint Issue Rate Million (CiPM) or Complaints per Million (CPM) broken down by product type and by time. Report Purpose / Business Driver: This report presents counts of complaints and issues on a product by product basis over time. The data shall be used to monitor variations in those complaints and issues over time.
For Review
ID/ Number
4.3.6.1
Requirement Text
The system shall contain a report called Overall Product Complaint Issues Rates. See Appendix F Overall Product Complaint/Issues Rates Report Report Specification for report requirements.
4.3.7
Top Product Complaint Cause Codes by Product
Report Description: This report presents in graph and table form the top five PC issues by product and by time. Report Purpose / Business Driver: The purpose of this report is to identify the top cause codes by product for a given period. The data shall be used to monitor variations in the top cause codes over time.
ID/ Number
4.3.7.1
Requirement Text
The system shall contain a report called Top Product Complaint Cause Codes. See Appendix G Top Product Complaint Cause Codes by Product Report Report Specification for report requirements.
4.3.8
Site/Partner Performance in Complaint Assessments Management
Report Description:
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
26 of 155
This report provides a bar graph and a data table showing the percentage of assessments that are on time, total number of assessments due and percent change that represents over the last reporting period, for all Amgen and non-Amgen manufacturing sites. Additional tables for both Amgen and non-Amgen sites present details of assessments for specific sites, by product type. Report Purpose / Business Driver: This report presents counts and percents of on-time assessments by site. The data shall be used to monitor assessment completion performance for Amgen and contract partners.
ID/ Number
4.3.8.1
Requirement Text
The system shall contain a report called Site/Partner Performance in Complaint Assessments Management. See Appendix H Site/Partner Performance in Complaint Assessments Management Report Report Specification for report requirements.
For Review
4.3.9
Periodic Product Complaint Excursion Report
Report Description: This report produces a data table and graphs depicting complaint types and rates over time. All the graphs take the same form of presenting the percentage of complaints per product falling one, two and three standard deviations above the baseline. The data tables all take the same format and present the raw PC records being graphed. Report Purpose / Business Driver: This report presents complaint rate trends by product. The data shall be used in periodic product complaint trending and analyzing those trends.
ID/ Number
4.3.9.1
Requirement Text
The system shall contain a report called Periodic Product Complaint Excursion Report. See Appendix I Periodic Product Complaint Excursion Report Report Specification for report requirements.
4.3.10 Complaint Issues with Failure Identified Report Report Description: The report provides a listing of all complaint issues for which a failure has been identified in the selected time period. Report Purpose / Business Driver:
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
27 of 155
This report identifies issue records with which there is an identified failure and associated details. The data shall be used in tracking the identified failures.
ID/ Number
4.3.10.1
Requirement Text
The system shall contain a report called Complaint Issues With Failure Identified Report. See Appendix J Complaint Issues With Failure Identified Report Report Specification for report requirements.
4.3.11 Drill Table Complaint Report Description: This is a drill down table and accessible only via other reports. The table presents the information of interest at the complaint level. Report Purpose / Business Driver: This table is used to present to the user detailed information relating to complaints. It is used in analysis and tracking of specific complaints
For Review
ID/ Number
4.3.11.1
Requirement Text
The system shall contain a report that permits a user to drill down to Complaint level detail. See Appendix K Drill Table Complaint Report Specification for report requirements.
4.3.12 Drill Table Issue Report Description: This is a drill down table and accessible only via other reports. The table presents the information of interest at the issue level. Report Purpose / Business Driver: This table is used to present to the user detailed information relating to issues. It is used in analysis and tracking of specific issues.
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
28 of 155
ID/ Number
4.3.12.1
Requirement Text
The system shall contain a report that permits a user to drill down to Issue level detail. See Appendix L Drill Table Issue Report Specification for report requirements.
4.3.13 Drill Table Assessment Report Description: This is a drill down table and accessible only via other reports. The table presents the information of interest at the assessment level. Report Purpose / Business Driver: This table is used to present to the user detailed information relating to assessments. It is used in analysis and tracking of specific assessments.
For Review
ID/ Number
4.3.13.1
Requirement Text
The system shall contain a report that permits a user to drill down to Assessment level detail. See Appendix M Drill Table Assessment Report Specification for report requirements.
4.3.14 Common Requirements Definitions The following are functional requirements that are common to all reports. Each report shall adhere to each individual requirement defined below.
ID/ Number
4.3.14.1
Requirement Text
Each standard report will have a PDF mode which presents the report in PDF format. See Appendices A through M.
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
29 of 155
ID/ Number
4.3.14.2
Requirement Text
Specific records are to be excluded from all reports and all counts presented in reports. Those report record exclusions are documented in Appendix A thru M in this document.
ID/ Number
4.3.14.3
Requirement Text
All reports will use the same basic header. The report title will be centered, and near the top of the header. There will be an Amgen logo in the upper left portion of the header. There will be a table on the bottom left of the header which displays the values selected in the standard filters and from prompts.
ID/ Number
4.3.14.4
For Review
Requirement Text
There shall be a standard report footer contained on all reports. It shall be comprised of the following four elements: Page X of Y The text Amgen Confidential User ID of the person who created the report Date and time the report was created
ID/ Number
4.3.14.5
Requirement Text
Records from CMIS where the IO Site is null shall be translated to Unk instead of blank.
4.4
Access Control
ID/ Number
4.4.1
Requirement Text
Access to core Subject Area tables and data shall be limited to users with database administrator and data administrator roles.
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
30 of 155
ID/ Number
4.4.2
Requirement Text
Access to data shall be controlled through the use of roles and privileges as defined in the PCMT Product Complaints Metrics & Trending (PCMT) Administration SOP (SOP-014441) The system shall be able to provide information on user access activities (logins and report execution).
4.4.3
4.5
System-wide Business Rules
Not applicable. All business rules are defined in the report, data, and universe specifications that are appendices in this document and in the Design Specification DS-00891.
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
31 of 155
5. Non-Functional Requirements
This section documents the non-functional requirements that have a direct impact upon the usability and acceptance of PCMT. This section documents the following non-functional requirements: 5.1 Usability 5.2 Dependability 5.3 Security 5.4 Performance 5.5 Traceability 5.6 Historical Data Requirements 5.7 Data Completeness and Accuracy Requirements 5.8 Data Reconciliation Requirements 5.9 System Availability Requirements 5.10 Report and Query Performance Requirements
For Review
5.1
Usability
This does not apply. All usability requirements are addressed in the report and universe specifications. See Appendix A Product Complaint Closure Performance Cycle Time Report Report Specification through Appendix M Drill Table Assessment Report Specification for report specifications. See Appendix E Universe Specification in the Design Specification DS-000891 for the universe specification.
5.2
Dependability
The system shall have an SLA and/or Administration SOP that shall document system dependability requirements.
5.3
5.3.1
Security
Security Classification
This section defines the security requirements to which PCMT will adhere.
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
32 of 155
ID/ Number
5.3.1.1
Requirement Text
PCMT shall use Single Sign On via Active Directory to validate usernames and passwords as directed by IS Security; Usernames and passwords will be the same as the users NT information. The system shall provide two levels of security:
5.3.1.2
o o
Report Users will have access to Self Service reports and the capabilities provided with those reports only. Power Users will have access to all reports and capabilities granted to Report Users plus full use of the ad hoc environment.
5.3.1.3
No user will have the ability to create, update or delete records in the PCMT data mart.
For Review
5.3.2
Confidentiality
ID/ Number
5.3.2.1 5.3.2.2
Requirement Text
No Personal Identifiable Information shall be stored in the PCMT data mart. All printed reports produced by PCMT will have Amgen Confidential centered at the bottom of every page.
5.4
5.4.1
Performance
Key Performance Indicators
ID/ Number
5.4.1.1
Requirement Text
The system shall provide an SLA addressing Subject Area data readiness and availability requirements of PCMT.
5.5
Traceability
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
33 of 155
ID/ Number
5.5.1.1
Requirement Text
Each table in the subject area shall have the following audit fields: Create By, Create Date, and Create Time. These fields shall be updated at the time a record is created in the ETL load process and do not reflect the source system audit information. Each table that supports updates in the subject area shall have the following audit fields: Update By, Update Date, Update Time. These fields shall be updated at the time a record is updated during the ETL load process. Note: See DS-000891 Product Complaints Metrics and Trending (PCMT) Design Specification Appendix B Core Load Strategy for identification of tables with update capabilities.
5.5.1.2
For Review
5.6
Historical Data Requirements

ID/ Number
5.6.1.1
Requirement Text
All data from CMIS beginning on 1 January 2004 to the present date will be loaded into the PCMT data mart.
5.7
Data Completeness and Accuracy Requirements
See Section 4.1.2 Transfer Data from the Staging Area to Data Core above.
5.8
Data Reconciliation Requirements
See Section 4.1.2 Transfer Data from the Staging Area to Data Core above.
5.9
System Availability Requirements
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
34 of 155
ID/ Number
5.9.1 5.9.2 5.9.3
Requirement Text
The data from CMIS into PCMT shall be refreshed at least once every 24 hours. The refresh of data from CMIS into PCMT shall be scheduled at a time that does not interfere with US or EU business hours. The system shall have an SLA that governs system availability.
5.10
Report and Query Performance Requirements
Report and query performance requirements are described in Appendix A Product Complaint Closure Performance Cycle Time Report Report Specification through Appendix M Drill Table Assessment Report Specification.
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
35 of 155
6. Procedural Requirements
6.1 Applicable Regulations
ID/ Number
6.1.1
Requirement Text
The system shall comply with applicable regulations specified in the PCMT System Compliance Assessment (SCA) (SCA-000329) concerning computer related systems (CRS).
6.2
Procedural Controls
ID/Number Requirement Text
6.2.1 Users shall be prevented from creating, modifying or deleting electronic records via the backend (i.e. creating, modifying or deleting electronic records shall only be available via the system user interface). Procedures shall exist that describe the control and documentation requirements for administrators making requested changes, additions, or deletions to system data by means other than through the application user interface (e.g. SQL script).
For Review
Reference
See Section 5.3.2 for access requirements. SOP-014441 PCMT Administration SOP-013934 EDW Administration and Operations For PCMT, this requirement is not applicable. PCMT is a reporting system only; CMIS is the system of record for product complaint data. STND-000027 Identity & Rights Management Standard
6.2.2
6.2.3
Procedures shall exist to ensure that electronic records generated by the system remain accurate and readily retrieval throughout the records retention period.
6.2.4
System shall adhere to Amgen User Access Policy for password security
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
36 of 155

6.2.5 Procedures shall exist to ensure that audit trails of electronic records generated by the system remain accurate and readily retrieval throughout the records retention period.
Reference
For PCMT, this requirement is not applicable. PCMT is a reporting system only; CMIS is the system of record for product complaint data. For PCMT, this requirement is not applicable. The only audit trails are generated during the data load process and cannot be disabled without modifying code and database structures. SOP-014441 PCMT Administration SOP-013934 EDW Administration and Operations
6.2.6
Procedures shall exist to prevent an administrator from disabling audit trail functions.
For Review
6.2.7
Personnel involved in developing the system shall have the appropriate education, training and experience, including GxP training as applicable.
6.2.8
Personnel involved in maintaining the system shall have the appropriate education, training and experience, including GxP Training as applicable.
SOP-014441 PCMT Administration SOP-013934 EDW Administration and Operations
6.2.9
Personnel granted access to the system shall have the appropriate training prior to being granted access including GxP Training as applicable.
SOP-014441 PCMT Administration
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
37 of 155

6.2.10 Procedures shall exist to hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.
Reference
For PCMT, this requirement is not applicable; there is no electronic signature functionality in this system. OS-000020 User Responsibility And Accountability For Computer Related Systems SOP-012212 Computer Related System Document Processing for Information Systems in EDM Quality SOP-001054 Controlled Document Processing for Information Systems in EDM Quality
6.2.11
All users and support personnel shall be informed of and required to acknowledge their accountability and responsibility for actions initiated when logged onto Amgen computer systems.
6.2.12
Procedures shall exist to control the distribution of, access to, and use of documentation for system operation and maintenance.
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
38 of 155

6.2.13 Procedures shall exist to ensure there is an audit trail that documents time-sequenced development and modification of systems documentation.
Reference
SOP-012212 Computer Related System Document Processing for Information Systems in EDM Quality SOP-001054 Controlled Document Processing for Information Systems in EDM Quality
For Review
6.2.14
Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.
For PCMT, this requirement is not applicable; there is no electronic signature functionality in this system. For PCMT, this requirement is not applicable; there is no electronic signature functionality in this system. For PCMT, this requirement is not applicable; there is no electronic signature functionality in this system. STND-000027 Identity & Rights Management Standard
6.2.15
Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.
6.2.16
Users shall electronically sign a record using only their own credentials.
6.2.17
The system shall have an automatic password expiration mechanism, or there shall be a procedure that requires the users password expire after a predetermined period, preventing access to the system until the users password has been changed.
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review
TITLE
3.4
39 of 155

6.2.18 The system shall provide security features that protect the system from unauthorized tampering or manipulation.
Reference
SOP-013934 EDW Administration and Operations
6.3
Business Continuity / Service Level Agreements

ID/ Number
6.3.1 6.3.2
Requirement Text
The PCMT Subject Area shall have a Service Level Agreement (SLA) that details the availability of new and updated data in PCMT data mart. The PCMT Subject Area shall have a Service Level Agreement (SLA) that details incident support response time.
For Review
6.4
Support
ID/ Number
6.4.1
Requirement Text
There shall be an administration SOP that governs the support of the PCMT application.
6.5
Training Procedures
ID/ Requirement Text Number
6.5.1 There shall be an administration SOP that defines the training requirements for PCMT users.
Amgen Confidential
DOCUMENT NO.
RS-000885
For Review Product Complaints Metrics & Trending (PCMT) - Requirements Specification
TITLE
3.4
40 of 155
The following notes are applicable to all of the Appendices: o o o Greyed out blank cells are Not Applicable Report Variable Design: The report variables represent business rules/calculations. In BusinessObjects, all PCMT reports shall be located per the folder path specified below: Public Folders PCMT: Complaint Issues with Failure Identified Report Interim Report Adherence Report Open vs Overdue Complaints Report Overall Product Complaint/Issue Rate Report Product Complaint Closure Performance Cycle Time Report Product Compliant Initiated Rate Report Right First Time Report Site Partner Performance In Complaint Assessment Management Report Top Product Complaint Cause Codes by Product Report Public Folders PCMT Drill Down reports: Assessments Drill Report Complaints Drill Report Issues Drill Report Public Folders PCMT Periodic Product Complaint Excursion/Trending Report: Periodic Product Complaint Excursion & Trending Report Summary Data* Periodic Product Complaint Excursion & Trending Report Trending Charts* * Details for the two Periodic Product Complaint Excursion Report bullets are documented as a single report in Appendix I. The Summary Data reflects information in sections I1 through I4, and the Trending Data reflects information in section I5.
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
41 of 155
A. APPENDIX A - Product Complaint Closure Performance Cycle Time Report Report Specification
A1 45 Days Tab A1.1 Report Fields
Due Date Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Column
IO Site Column
Record Type Row
OverDue-OnTime Row Body
Count Body
Prct
For Review
1st Column Break Total Hyperlink Yes Dimensions / Complaints / Complaint Due Date (45 Days) / Complaint Due Month (45 Days)
1st Row Break Total Complaints Hyperlink Yes Dimensions / Complaints / Complaint Investigating Site/Dept / IO Site Custom Objects / Complaint OverDue-OnTime Status(45 Days) Sum([Number Of Complaints (with Drill)]) Hyperlink [Percentage Of PCs] ##%
Dimensions / Complaints / Record Type
[Number Of Complaints (with Drill)]
[Percentage Of PCs]
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
42 of 155
Complaint Type
Product Name
Complaint Status Not Displayed In report
Complaint Due Quarter (45 Days) Not Displayed In report
Complaint Due Month (45 Days) Not Displayed In report
Complaint Due Year (45 Days) Not Displayed In report
Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule
Not Displayed In report
Not Displayed In report
Yes
Yes Dimensions / Complaints / Product / Product Name
Yes Dimensions / Complaints / Complaint Status
Dimensions / Complaints / Complaint Type
Yes Dimensions / Complaints / Complaint Due Date (45 Days) / Complaint Due Quarter (45 Days)
Yes Dimensions / Complaints / Complaint Due Date (45 Days) / Complaint Due Month (45 Days)
Yes Dimensions / Complaints / Complaint Due Date (45 Days) / Complaint Due Year (45 Days)
For Review
A1.2 Prompts Not applicable No prompts specified for this report. A1.3 Filter Conditions
Column/Filter Name Complaint Type Operator Not Equal Value Clinical - Type2 Universe Object / Filter Dimensions / Complaints / Complaint Type
A1.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report.
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
43 of 155
A1.5 Drill Up / Drill Down and Links

Drill/Link Name Complaint Due Date Drill Drill Path / Link To Complaint Due Year <-> Complaint Due Quarter <--> Complaint Due Month IO Site -> IO Dept Compalints Drill Report Description Time dimension drill down from Year -> Quarter -> Month
IO Site Drill Overdue On Time Drill
IO Site/Dept from down from Site to Dept The link Passes all the Interactive filter values (if available) and IO Site , Due Date to Complaints drill report and shows a detail report.
A1.6 Security Requirements

Security Requirement PCMT Users PCMT Super Users Description Can view in HTML and Only Export to PDF Can view in HTML and Export to PDF and Excel
For Review
A1.7 Performance Requirements

Performance Class Class B Condition Under 30 seconds
A1.8 Print Requirements

Requirement Print View Description Landscape
A1.9 Query Design

Query 45 Days Query Purpose Main Query
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
44 of 155
A1.10 Report Variables Design

Variable CycleTime-Initiated To Closed Number Of Complaints (with Drill) (30 days) Number Of Complaints (with Drill) (45 days) # of PCs Closed OnTime (30 Days) % of PCs Closed OnTime (30 Days) # of PCs Closed OnTime (45 Days) % of PCs Closed OnTime (45 Days) Percentage Of PCs (30 days) Percentage Of PCs (45 days) Purpose If IsNull([45 Days Query].[Complaint Closed Date]) Then DaysBetween([45 Days Query].[Complaint Initiated Date];[45 Days Query].[Complaint Voided Date]) Else DaysBetween([45 Days Query].[Complaint Initiated Date];[45 Days Query].[Complaint Closed Date]) [30 Days Query].[Number of Complaints] [45 Days Query].[Number of Complaints] [30 Days Query].[Number of Complaints] Where([Complaint OverDue-OnTime Status(30 days)]="OnTime-Closed") Percentage([# of PCs Closed OnTime (30 Days)];Col) [45 Days Query].[Number of Complaints] Where([Complaint OverDue-OnTime Status(45 Days)]="OnTime-Closed") Percentage([# of PCs Closed OnTime (45 Days)];Col) Percentage([30 Days Query].[Number of Complaints];Col) Percentage([45 Days Query].[Number of Complaints];Col)
For Review
A2 30 Days Tab A2.1 Report Fields

Due Date Column IO Site Column Record Type Row OverDue-OnTime Row Count Body Prct Body
1st Column Break Total Hyperlink Yes Dimensions / Complaints / Complaint Due Date (30 Days) / Complaint Due Month (30 Days) Hyperlink
1st Row Break Total Complaints
Sum([Number Of Complaints (with Drill)]) Hyperlink Custom Objects / Complaint OverDueOnTime Status(30 Days) [Number Of Complaints (with Drill)]
[Percentage Of PCs] ##% [Percentage Of PCs]
Yes Dimensions / Complaints / Complaint Investigating Site/Dept / IO Site Dimensions / Complaints / Record Type
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
45 of 155
Complaint Type Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Not Displayed In report
Product Name Not Displayed In report
Complaint Status Not Displayed In report
Complaint Due Quarter (30 Days) Not Displayed In report
Complaint Due Month (30 Days) Not Displayed In report
Complaint Due Year (30 Days) Not Displayed In report
For Review
Yes Dimensions / Complaints / Complaint Type
Yes Dimensions / Complaints / Product / Product Name
Yes Dimensions / Complaints / Complaint Status
Yes Dimensions / Complaints / Complaint Due Date (30 Days) / Complaint Due Quarter (30 Days)
Yes Dimensions / Complaints / Complaint Due Date (30 Days) / Complaint Due Month (30 Days)
Yes Dimensions / Complaints / Complaint Due Date (30 Days) / Complaint Due Year (30 Days)
A2.2 Prompts Not applicable No prompts specified for this report. A2.3 Filter Conditions
Column/Filter Name Complaint Type Operator Not Equal Value Clinical - Type2 Universe Object / Filter Dimensions / Complaints / Complaint Type
A2.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report.
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
46 of 155
A2.5 Drill Up / Drill Down and Links

Drill/Link Name Complaint Due Date Drill Drill Path / Link To Complaint Due Year <-> Complaint Due Quarter <--> Complaint Due Month IO Site -> IO Dept Compalints Drill Report Description Time dimension drill down from Year -> Quarter -> Month
IO Site Drill Overdue On Time Drill
IO Site/Dept from down from Site to Dept The link Passes all the Interactive filter values (if available) and IO Site , Due Date to Complaints drill report and shows a detail report.
A2.6 Security Requirements

For Review
A2.7 Performance Requirements

A2.8 Print Requirements

Requirement Print View Description Landscape
A2.9 Query Design

Query 30 Days Query Purpose Main Query
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
47 of 155
A2.10 Report Variables Design

Variable CycleTime-Initiated To Closed Number Of Complaints (with Drill) (30 days) Number Of Complaints (with Drill) (45 days) # of PCs Closed OnTime (30 Days) % of PCs Closed OnTime (30 Days) # of PCs Closed OnTime (45 Days) % of PCs Closed OnTime (45 Days) Percentage Of PCs (30 Days) Percentage Of PCs (45 Days) Purpose If IsNull([45 Days Query].[Complaint Closed Date]) Then DaysBetween([45 Days Query].[Complaint Initiated Date];[45 Days Query].[Complaint Voided Date]) Else DaysBetween([45 Days Query].[Complaint Initiated Date];[45 Days Query].[Complaint Closed Date]) [30 Days Query].[Number of Complaints] [45 Days Query].[Number of Complaints] [30 Days Query].[Number of Complaints] Where([Complaint OverDue-OnTime Status(30 days)]="OnTime-Closed") Percentage([# of PCs Closed OnTime (30 Days)];Col) [45 Days Query].[Number of Complaints] Where([Complaint OverDue-OnTime Status(45 Days)]="OnTime-Closed") Percentage([# of PCs Closed OnTime (45 Days)];Col) Percentage([30 Days Query].[Number of Complaints];Col) Percentage([45 Days Query].[Number of Complaints];Col)
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
48 of 155
B. APPENDIX B - Product Complaint Initiated Rate Report Report Specification

B1 PC Initiated Rate Data B1.1 Report Fields
Complaint Type Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Column 1st Column Break Record Type Column 2nd Column Break Complaint Initiated Year Column 3rd Column Break HyperLink Yes Dimensions/Complai nts/Complaints Initiated Date/Complaint Initiated Year Product Name IO Site Column 4th Column Break SubTotal by Site / Grand Total HyperLink Dimensions/Complai nts/Complaint Investigating Site/Dept/IO Site Dimensions/Complai nts/Investigation Level HyperLink Measures/Complaint Measures/Number of Complaints Yes Dimensions/Complai nts/Complaint Type Yes Dimensions/Complai nts/Rrecord Type Investigation Level Column Number of Records Column
For Review
Complaint Owner Count Column
Ratio - Records to Owners Column
Delivery System
Complaint Initiated Quarter
Complaint Initiated Month
Yes Measures/Complaint Measures/Number of Complaint Owners Report Variable Dimensions/Complai nts/Product/Product Name
Yes Dimensions/Complai nts/Product/Delivery System
Yes Dimensions/Complai nts/Complaints Initiated Date/Complaint Initiated Quarter
Yes Dimensions/Complai nts/Complaints Initiated Date/Complaint Initiated Month
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
49 of 155
B1.2 Prompts Not applicable No prompts specified for this report. B1.3 Filter Conditions
Column/Filter Name Complaint Type Complaint Status Operator Not Equal to Not Equal to Value Clinical Type-2 Voided Universe Object / Filter Dimensions/Complaints/Complaint Type Dimensions/Complaints/Complaint Status
For Review
B1.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report. B1.5 Drill Up / Drill Down and Links
Drill/Link Name IO Site Number of Records Complaint Initiated Year Drill Path / Link To IO Site -> IO Dept Complaints Drill Report Complaint Initiated Year <-> Complaint Initiated Quarter <-> Complalint Initiated Month Description The link drills from IO Site to IO Department The link passes the Complaint number and shows the detail drill report for the complaint number clicked on The link drills Up or Down from Complaint Initiated Year <-> Complaint Initiated Quarter <-> Complaint Initiated Month
B1.6 Security Requirements

B1.7 Performance Requirements

Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
50 of 155
B1.8 Print Requirements

Requirement Print View Description
B1.9 Query Design Not applicable no specific query design specified for this report. B1.10 Report Variables Design
Variable CPM IO Site(No Drill) Complaint Owner Count Percentage Of Records Ratio - Complaints to Owners Purpose If([Distribution Quantity]>0) Then ([Number of Complaints]/[Distribution Quantity]*1000000) Else 0 [IO Site] Count([Complaint Owner Staff Key];Distinct) Percentage([Number of Complaints];Row) Round([Number of Complaints]/[Complaint Owner Count];0)
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
51 of 155
B2 CPM Chart by IO Site B2.1A Report Fields - Graph

Complaint Initiated Year Column Complaint Initiated Quarter Complaint Initiated Month X Axis Number Of Complaints Y Axis Product Name Delivery System
Yes Yes Dimensions/Complai nts/Complaints Initiated Date/Complaint Initiated Year IO Site Yes Dimensions/Complai nts/Complaints Initiated Date/Complaint Initiated Quarter Record Type Dimensions/Complai nts/Complaints Initiated Date/Complaint Initiated Year, Quarter and Month Complaint Type Measures/Complaint Measures/Number Of Complaints
Yes Dimensions/Complai nts/Product/Product Name
For Review
Product Reported Name
Data Plotted
Yes Dimensions/Complai nts/Complaint Investigating Site/Dep/IOSite
Yes Dimensions/Complai nts /Record Type
Yes Dimensions/ Complaint/Complaint Type
Yes Dimensions/Complai nts/Product Reported/Product Reported Name
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
52 of 155
B2.1B Report Fields Cross Tab

IO Site Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Column Complaint Initiated Month Row Number Of Records Row Distribution Quantity Row
Hyperlink Dimensions/Complai nts/Complaint Investigating Site/Dep/IOSite Dimensions/Complai nts/Complaints Initiated Date/Complaint Initiated Year, Quarter and Month
Hyperlink Measures/Complaint Measures/Number Of Complaints Measures/Distributio n Quantity Measures/ Distribution Quantity
For Review
B2.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report.
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
53 of 155
B2.5 Drill Up / Drill Down and Links

Drill/Link Name Number of Records Complaint Initiated Month Drill Path / Link To Complaints Drill Report Complaint Initiated Year <-> Complaint Initiated Quarter <-> Complalint Initiated Month Description The link passes the Complaint number and shows the detail drill report for the complaint number clicked on The link drills Up or Down from Complaint Initiated Year <-> Complaint Initiated Quarter <-> Complaint Initiated Month

For Review


B2.9 Query Design Not applicable no specific query design specified for this report.
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
54 of 155
B2.10 Report Variables Design

For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
55 of 155
B3 % of PCs by Level B3.1A Report Fields Graph

Record Investigation Level X Axis Percentage Of Records Y Axis Complaint Initiated Year Complaint Initiated Quarter Data Plotted Complaint Initiated Month Product Name
Dimensions/Complai nts/Investigation Level Delivery System
Measures/Complaint Measures/Number Of Complaints Record Type
Yes Dimensions/Complai nts/Complaints Initiated Date/Complaint Initiated Year Complaint Type
Yes Dimensions/Complai nts/Complaints Initiated Date/Complaint Initiated Quarter
Yes Dimensions/Complai nts/Complaints Initiated Date/Complaint Initiated Month
Yes Dimensions/Complai nts/Product/Product Name
For Review
Yes Dimensions/Complai nts /Record Type
Yes Dimensions/Complai nts/Complaint Type
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
56 of 155
B3.1B Report Fields Cross Tab

Investigation Level Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Row Complaint Initiated Month Row Number of Records Row
Hyperlink Dimensions/Complai nts/Investigation Level Dimensions/Complai nts/Complaints Initiated Date/Complaint Initiated Year, Quarter and Month
Hyperlink Measures/Complaint Measures / Number Of Complaints
For Review
B3.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report. B3.5 Drill Up / Drill Down and Links
Drill/Link Name Number Of Records Drill Path / Link To Complaints Drill Report Description The link passes the Complaint number and shows the detail drill report for the complaint number clicked on
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
57 of 155
Complaint Initiated Month
Complaint Initiated Year <-> Complaint Initiated Quarter <-> Complalint Initiated Month
The link drills Up or Down from Complaint Intiated Year <-> Complaint Initiated Quarter <-> Complaint Initiated Month


For Review

B3.9 Query Design Not applicable no specific query design specified for this report. B3.10 Report Variables Design
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
58 of 155
C. APPENDIX C - Right First Time Report Report Specification

C1 Main Report C1.1 Report Fields
Special Format as displayed below - Blue/Green cells are Text Items; All others are single cell formulas. IO Site Number ATO ELC Sample Size ATO Sample Size ELC Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule LI RowPcnt TotalCompsForA PctCompsForAT TOLI OLI TotalCompsForE PctCompsForEL LCLI CLI SampleSizeNumberATOLI SampleSizeNumberELCLI Investigation Level LII Number IO Total RowPcnt TotalCompsForA TO TotalCompsForE LC Sample Size SampleSizeLette rATO SampleSizeLette rELC Number Sampled SampleSizeDispl ayATO SampleSizeDispl ayELC
TotalCompsForA PctCompsForAT TOLII OLII TotalCompsForE PctCompsForEL LCLII CLII SampleSizeNumberATOLII SampleSizeNumberELCLII
For Review
see above
see above
see above
see above
see above
see above
hyperlink TotalCompsForATO LI
0.00% PctCompsForATOLI
hyperlink TotalCompsForATO LII
0.00% PctCompsForATOLII
hyperlink TotalCompsForATO SampleSizeLetterAT O
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
59 of 155
Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule
see above
see above
see above
see above
see above
see above
hyperlink SampleSizeDisplayA TO TotalCompsForELC LI
0.00% PctCompsForELCLI
hyperlink TotalCompsForELC LII
0.00% PctCompsForELCLII
hyperlink TotalCompsForELC
For Review
see above
see above
see above
see above
see above
see above
hyperlink SampleSizeLetterEL C SampleSizeDisplayE LC SampleSizeNumber ATOLI
hyperlink SampleSizeNumber ATOLII
hyperlink SampleSizeNumber ELCLI
hyperlink SampleSizeNumber ELCLII
C1.2 Prompts
Prompt order 1 2 Description Complaint Closed Date(Start) Complaint Closed Date(End) Display Text Enter Complaint Closed Date(Start): Enter Complaint Closed Date(End): Operator Between Required/ Optional Required Required Single/Multi Single Single Type Date Date Default Values
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
60 of 155
C1.3 Filter Conditions

Column/Filter Name Investigation Level Complaint Status Record Type Complaint Type Operator InList Equal to Equal To Not in List Value LI;LII Closed Product Complaint ?;Clinical - Type 2 Universe Object / Filter
C1.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report. C1.5 Drill Up / Drill Down and Links
Drill/Link Name Drill to Right First Time Detail Report Drill Path / Link To Public Folders -> PCMT -> Drill Reports -> Right First Time Detail Report Description Sample Size ATO and ELC values for each Investigation Level should link to the Right First Time Detail report to list a random sample of Product Complaint records
For Review
C1.6 Security Requirements

C1.7 Performance Requirements

C1.8 Print Requirements

Requirement Print View Description Landscape, A4
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
61 of 155
C1.9 Query Design

Query Complaints Purpose Main Query
C1.10 Report Variables Design Note: Sample Size calculation: Reference SOP-012109 section 6.2 to 6.4.
Variable vClosedDate(End) vClosedDate(Start) PctCompsForATOLI PctCompsForATOLII PctCompsForELCLI PctCompsForELCLII SampleSizeDisplayATO Purpose UserResponse("Enter Complaint Closed Date(End):") UserResponse("Enter Complaint Closed Date(Start):") [TotalCompsForATOLI]/[TotalCompsForATO] [TotalCompsForATOLII]/[TotalCompsForATO] [TotalCompsForELCLI]/[TotalCompsForELC] [TotalCompsForELCLII]/[TotalCompsForELC] If [TotalCompsForATO] Between(2;8) Then 2 ElseIf [TotalCompsForATO] Between(9;15) Then "3+" ElseIf [TotalCompsForATO] Between(16;25) Then "5+" ElseIf [TotalCompsForATO] Between(26;50) Then "8+" ElseIf [TotalCompsForATO] Between(51;90) Then "13+" ElseIf [TotalCompsForATO] Between(91;150) Then "20" ElseIf [TotalCompsForATO] Between(151;280) Then "32" ElseIf [TotalCompsForATO] Between(281;500) Then "50" ElseIf [TotalCompsForATO] Between(501;1200) Then "80" ElseIf [TotalCompsForATO] Between(1201;3200) Then "125" ElseIf [TotalCompsForATO] Between(3201;10000) Then "200" ElseIf [TotalCompsForATO] Between(10001;35000) Then "315" ElseIf [TotalCompsForATO] Between(35001;150000) Then "500" ElseIf [TotalCompsForATO] Between(150001;500000) Then "800" ElseIf [TotalCompsForATO]>=500001 Then "1250" Else "2000" If [TotalCompsForELC] Between(2;8) Then "2" ElseIf [TotalCompsForELC] Between(9;15) Then "3+" ElseIf [TotalCompsForELC] Between(16;25) Then "5+" ElseIf [TotalCompsForELC] Between(26;50) Then "8+" ElseIf [TotalCompsForELC] Between(51;90) Then "13+" ElseIf [TotalCompsForELC] Between(91;150) Then "20" ElseIf [TotalCompsForELC] Between(151;280) Then "32" ElseIf [TotalCompsForELC] Between(281;500) Then "50" ElseIf [TotalCompsForELC] Between(501;1200) Then "80" ElseIf [TotalCompsForELC] Between(1201;3200) Then "125" ElseIf [TotalCompsForELC] Between(3201;10000) Then "200" ElseIf [TotalCompsForELC] Between(10001;35000) Then "315" ElseIf [TotalCompsForELC] Between(35001;150000) Then "500" ElseIf [TotalCompsForELC] Between(150001;500000) Then "800" ElseIf [TotalCompsForELC]>=500001 Then "1250" Else "2000" If [TotalCompsForATO] Between(2;8) Then A" ElseIf [TotalCompsForATO] Between(9;15) Then "B" ElseIf [TotalCompsForATO] Between(16;25) Then "C" ElseIf [TotalCompsForATO] Between(26;50) Then "D" ElseIf [TotalCompsForATO] Between(51;90) Then "E" ElseIf [TotalCompsForATO] Between(91;150) Then "F" ElseIf [TotalCompsForATO] Between(151;280) Then "G" ElseIf [TotalCompsForATO] Between(281;500) Then "H" ElseIf [TotalCompsForATO] Between(501;1200) Then "J" ElseIf [TotalCompsForATO] Between(1201;3200) Then "K" ElseIf [TotalCompsForATO] Between(3201;10000) Then "L" ElseIf [TotalCompsForATO] Between(10001;35000) Then "M" ElseIf [TotalCompsForATO] Between(35001;150000) Then "N" ElseIf [TotalCompsForATO] Between(150001;500000) Then "P" ElseIf [TotalCompsForATO]>=500001 Then "Q" Else "R" ForEach([IO Site])
For Review
SampleSizeDisplayELC
SampleSizeLetterATO
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
62 of 155
Variable SampleSizeLetterELC
SampleSizeNumberATO
SampleSizeNumberATOLI SampleSizeNumberATOLII SampleSizeNumberELC
SampleSizeNumberELCLI SampleSizeNumberELCLII TotalCompsForATO TotalCompsForATOLI TotalCompsForATOLII TotalCompsForELC TotalCompsForELCLI TotalCompsForELCLII DrillATOLI
Purpose If [TotalCompsForELC] Between(2;8) Then "A" ElseIf [TotalCompsForELC] Between(9;15) Then "B" ElseIf [TotalCompsForELC] Between(16;25) Then "C" ElseIf [TotalCompsForELC] Between(26;50) Then "D" ElseIf [TotalCompsForELC] Between(51;90) Then "E" ElseIf [TotalCompsForELC] Between(91;150) Then "F" ElseIf [TotalCompsForELC] Between(151;280) Then "G" ElseIf [TotalCompsForELC] Between(281;500) Then "H" ElseIf [TotalCompsForELC] Between(501;1200) Then "J" ElseIf [TotalCompsForELC] Between(1201;3200) Then "K" ElseIf [TotalCompsForELC] Between(3201;10000) Then "L" ElseIf [TotalCompsForELC] Between(10001;35000) Then "M" ElseIf [TotalCompsForELC] Between(35001;150000) Then "N" ElseIf [TotalCompsForELC] Between(150001;500000) Then "P" ElseIf [TotalCompsForELC]>=500001 Then "Q" Else "R" ForEach([IO Site]) Sum(If [TotalCompsForATO] Between(2;8) Then 2 ElseIf [TotalCompsForATO] Between(9;15) Then 4 ElseIf [TotalCompsForATO] Between(16;25) Then 6 ElseIf [TotalCompsForATO] Between(26;50) Then 9 ElseIf [TotalCompsForATO] Between(51;90) Then 14 ElseIf [TotalCompsForATO] Between(91;150) Then 20 ElseIf [TotalCompsForATO] Between(151;280) Then 32 ElseIf [TotalCompsForATO] Between(281;500) Then 50 ElseIf [TotalCompsForATO] Between(501;1200) Then 80 ElseIf [TotalCompsForATO] Between(1201;3200) Then 125 ElseIf [TotalCompsForATO] Between(3201;10000) Then 200 ElseIf [TotalCompsForATO] Between(10001;35000) Then 315 ElseIf [TotalCompsForATO] Between(35001;150000) Then 500 ElseIf [TotalCompsForATO] Between(150001;500000) Then 800 ElseIf [TotalCompsForATO]>=500001 Then 1250 Else 2000) Round([PctCompsForATOLI]*[SampleSizeNumberATO];0) [SampleSizeNumberATO]-[SampleSizeNumberATOLI] Sum(If [TotalCompsForELC] Between(2;8) Then 2 ElseIf [TotalCompsForELC] Between(9;15) Then 4 ElseIf [TotalCompsForELC] Between(16;25) Then 6 ElseIf [TotalCompsForELC] Between(26;50) Then 9 ElseIf [TotalCompsForELC] Between(51;90) Then 14 ElseIf [TotalCompsForELC] Between(91;150) Then 20 ElseIf [TotalCompsForELC] Between(151;280) Then 32 ElseIf [TotalCompsForELC] Between(281;500) Then 50 ElseIf [TotalCompsForELC] Between(501;1200) Then 80 ElseIf [TotalCompsForELC] Between(1201;3200) Then 125 ElseIf [TotalCompsForELC] Between(3201;10000) Then 200 ElseIf [TotalCompsForELC] Between(10001;35000) Then 315 ElseIf [TotalCompsForELC] Between(35001;150000) Then 500 ElseIf [TotalCompsForELC] Between(150001;500000) Then 800 ElseIf [TotalCompsForELC]>=500001 Then 1250 Else 2000) Round([PctCompsForELCLI]*[SampleSizeNumberELC];0) Round([PctCompsForELCLII]*[SampleSizeNumberELC];0) Sum(If [IO Site]="ATO" Then [Number of Complaints] Else 0) ForAll ([IO Site]) Sum(If [IO Site]="ATO" And [Investigation Level]="LI" Then [Number of Complaints] Else 0) ForAll ([IO Site]) Sum(If [IO Site]="ATO" And [Investigation Level]="LII" Then [Number of Complaints] Else 0) ForAll ([IO Site]) Sum(If [IO Site]="ELC" Then [Number of Complaints] Else 0) ForAll ([IO Site]) Sum(If [IO Site]="ELC" And [Investigation Level]="LI" Then [Number of Complaints] Else 0) ForAll ([IO Site]) Sum(If [IO Site]="ELC" And [Investigation Level]="LII" Then [Number of Complaints] Else 0) ForAll ([IO Site]) "<a href=\"../../opendoc/openDocument.jsp?iDocID=AXasey3M8NlJrS56ItHALIs&sIDType=CUID&sType=wid&lsSInvestigating%20Site=ATO &lsSInvestigation%20Level=LI&lsSPlease%20enter%20sample%20size="+URLEncode(""+[SampleSizeNumberATOLI])+"&lsSEnter%2 0Complaint%20Closed%20Date(Start)%3A="+URLEncode(""+[vClosedDate(Start)])+"&lsSEnter%20Complaint%20Closed%20Date(End )%3A="+URLEncode(""+[vClosedDate(End)])+"&sWindow=New\" title=\"\" target=\"_self\" nav=\"doc\">"+[SampleSizeNumberATOLI]+"</a>"
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
63 of 155
Variable DrillATOLII
DrillELCLI
DrillELCLII
Purpose "<a href=\"../../opendoc/openDocument.jsp?iDocID=AXasey3M8NlJrS56ItHALIs&sIDType=CUID&sType=wid&lsSInvestigating%20Site=ATO &lsSInvestigation%20Level=LII&lsSPlease%20enter%20sample%20size="+URLEncode(""+[SampleSizeNumberATOLII])+"&lsSEnter% 20Complaint%20Closed%20Date(Start)%3A="+URLEncode(""+[vClosedDate(Start)])+"&lsSEnter%20Complaint%20Closed%20Date(En d)%3A="+URLEncode(""+[vClosedDate(End)])+"&sWindow=New\" title=\"\" target=\"_self\" nav=\"doc\">"+[SampleSizeNumberATOLII]+"</a>" "<a href=\"../../opendoc/openDocument.jsp?iDocID=AXasey3M8NlJrS56ItHALIs&sIDType=CUID&sType=wid&lsSInvestigating%20Site=ELC &lsSInvestigation%20Level=LI&lsSPlease%20enter%20sample%20size="+URLEncode(""+[SampleSizeNumberELCLI])+"&lsSEnter%20 Complaint%20Closed%20Date(Start)%3A="+URLEncode(""+[vClosedDate(Start)])+"&lsSEnter%20Complaint%20Closed%20Date(End) %3A="+URLEncode(""+[vClosedDate(End)])+"&sWindow=New\" title=\"\" target=\"_self\" nav=\"doc\">"+[SampleSizeNumberELCLI]+"</a>" "<a href=\"../../opendoc/openDocument.jsp?iDocID=AXasey3M8NlJrS56ItHALIs&sIDType=CUID&sType=wid&lsSInvestigating%20Site=ELC &lsSInvestigation%20Level=LII&lsSPlease%20enter%20sample%20size="+URLEncode(""+[SampleSizeNumberELCLII])+"&lsSEnter%2 0Complaint%20Closed%20Date(Start)%3A="+URLEncode(""+[vClosedDate(Start)])+"&lsSEnter%20Complaint%20Closed%20Date(End )%3A="+URLEncode(""+[vClosedDate(End)])+"&sWindow=New\" title=\"\" target=\"_self\" nav=\"doc\">"+[SampleSizeNumberELCLII]+"</a>"
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
64 of 155
C2 Drill Report C2.1 Report Fields

ID Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Column Complaint No. Column Complaint Status Code Column Record Type Column Complaint Type Column Product Column
TotalCompsForATO LI
Dimensions / Complaints / Complaint No.
Dimensions / Complaints / Complaint Status
Dimensions / Complaints / Product / Product Name
For Review
Pack Lot No Column
IO Site Column
Closed Date Column
Owner Name Column
Investigation Level Column
Dd/Mon/yy Dimensions / Complaints / Lot / Pack Lot No. Dimensions / Complaints / Complaint Investigating Site/Dept / IO Site Dimensions / Complaints / Complaint Closed Date / Complaint Closed Date Dimensions / Complaints / Complaint Owner Name Dimensions / Complaints / Investigation Level
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
65 of 155
C2.2 Prompts
Prompt order 1 2 3 4 5 Description Investigating Site Investigation Level Sample Size Complaint Closed Date(Start) Complaint Closed Date(End) Display Text Investigating Site Investigation Level Please enter sample size Enter Complaint Closed Date(Start): Enter Complaint Closed Date(End): Operator In List In List Sample Between Required/ Optional Required Required Required Required Required Single/Multi Single Single Single Single Single Type Character Character Number Date Date Default Values
For Review
C2.3 Filter Conditions

Column/Filter Name Complaint Status Record Type Complaint Type Operator Equal to Equal To Not in List Value Closed Product Complaint ?;Clinical - Type 2 Universe Object / Filter
C2.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report. C2.5 Drill Up / Drill Down and Links Not applicable No drill up / drill down or links specified for this report. C2.6 Security Requirements
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
66 of 155
C2.7 Performance Requirements

C2.8 Print Requirements

Requirement Print View Description Landscape, A4
C2.9 Query Design

Query Query 1 Purpose Main Query
For Review
C2.10 Report Variables Design

Variable Level NewLevel vID Purpose Substr([Investigation Level];2;2) UserResponse("Enter value(s) for Investigation Level:") LineNumber()-1
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
67 of 155
D. APPENDIX D - Interim Report Adherence Report Report Specification

D1 Report Fields
Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Complaint No. Column Ascending hyperlink Yes Dimensions / Complaints / Complaint Number Dimensions / Complaints / Record Type Dimensions / Issues / Risk Dimensions / Complaints / Complaint Owner Name Interim Report Assessment Number Column [Current Complaint Status] Dimension / Complaints / Complaint Event Summary Record Type Column Risk Column Owner Name Column Current Status Column Event Summary Column
For Review
Days Open As Of Report Date Column
Past Due As Of Report Date Column
Days Past Due As Of Report Date Column
Current Status Column
Assessment Type Column
hyperlink [Days Open As Of Report Date] [Past Due As Of Report Date] [Days Past Due As Of Report Date] [Interim Report Assessment Number] [Interim Report Assessment Current Status] [Interim Report Assessment Type]
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
68 of 155
Interim Report Present? Column
Interim Report On Time? Column
Past Due? Column
E-Sig On Time Column
# Cycles Open Column
[Interim Report Present ?]
[Interim Report On Time?]
[Interim Report Past Due ?]
[vEsignOnTime]
[Interim Report Number Of Cycles Open]
For Review
D2 Prompts
Prompt order Description Display Text Operator Required/ Optional Single/Multi Type Default Values
Not application no prompts for this report D3 Filter Conditions

Combination Logic AND Column/Filter Name Complaint Type Complaint Closed Date Past Due As of Report Date Complaint Status Unique Identifier Operator Not Equal To Is Null Value Clinical - Type 2 Universe Object / Filter Complaint Type Comments Query Level Filter Query Level Filter This is a report level Block Filter This is a report level Block Filter This is a report level Block Filter This is a report level Block Filter
In List Not Equal To In List Greater Than or Equal To
Y Voided 1 09/10/2008 12:00:00 AM
Report Variable: Past Due As of Report Date Dimensions/Complaints /Complaint Status Report Variable: Unique Identifier Dimensions/Complaints/ Complaint Initiated Date/ Complaint Initiated Date
Complaint Initiated Date
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
69 of 155
D4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report.
Alerter Name Alerter-DisplayBlankAssmntNumberCurrentStatusAssmtType Purpose To hide columns Assessment Number, Current Status and Assessment Type when there is no Interim Reprot.
D5 Drill Up / Drill Down and Links

Drill/Link Name Complaint Drill Drill Path / Link To Complaint Number Links to Complaint Drill Report Assessment Number Links to Assessment Drill Report Description "<a href=\"../../opendoc/openDocument.jsp?iDocID=ASFH8HAFr8ZBhdxnlqgnTz8&sIDType=CUID&sType=wid&sRefr esh=N&lsSEnter%20Complaint%20Number%3A="+URLEncode(""+[Complaint Number])+"&sWindow=New\" title=\"\" target=\"_self\" nav=\"doc\">"+[Complaint Number]+"</a>" "<a href=\"../../opendoc/openDocument.jsp?iDocID=ARICzJTtaUZBspsRUOX09cc&sIDType=CUID&sType=wid&lsSE nter%20Assessment%20Number%3A="+URLEncode(""+[Interim Report Assessment Number])+"&sWindow=New\" title=\"\" target=\"_self\" nav=\"doc\">"+[Interim Report Assessment Number]+"</a>"
For Review
Assessment Drill
D6 Security Requirements
D7 Performance Requirements
D8 Print Requirements
Requirement Print View Description Landscape; 1 page wide; Legal
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
70 of 155
D9 Query Design
Query Query 1 - Combined Query 1 Query 1 - Combined Query 2 Purpose Fetches all complaints that meet the selection criteria - includes complaints that have one or more assessments Fetches all complaints that meet the selection criteria - includes complaints that have zero or more assessments
D10 Report Variables Design

Variable Current Complaint Status DueDate Interim Report Assessment Current Status Interim Report Assessment Number Interim Report Assessment Type Interim Report On Time? Interim Report Present ? Past Due As Of Report Date Prior Cycle End Date Prior Cycle Start Date vEsignOnTime Days Between Complaint Initiated and Latest eSig Days Between Complaint Initiated and Prior Cycle End Purpose [Complaint Open/Closed Status] If [Record Type]="Product Complaint" Then RelativeDate([Complaint Initiated Date];+45) Else RelativeDate([Complaint Initiated Date];+60) [Assessment Status] [Assessment Number] [Assessment Type] If [Interim Report Present ?]="N" Then "N" ElseIf ([Record Type]="Product Complaint" And DaysBetween([Complaint Initiated Date];[Assessment Opened Date]) > 45) Then "N" ElseIf DaysBetween([Complaint Initiated Date];[Assessment Opened Date]) > 60 Then "N" Else "Y" If [Assessment Type]="Interim Report" Then "Y" Else "N" If ([Record Type]="Product Complaint" And DaysBetween([Complaint Initiated Date];CurrentDate()) > 45) Then "Y" ElseIf DaysBetween([Complaint Initiated Date];CurrentDate()) > 60 Then "Y" Else "N" RelativeDate([DueDate];45*([Interim Report Number Of Cycles Open]-1)) RelativeDate([Prior Cycle End Date];-45) If [Interim Report Present ?]="N" Then "N" ElseIf ([Interim Report Number Of Cycles Open]=1 And [Assessment Signed Date] Between([Complaint Initiated Date];[DueDate])) Then "Y" ElseIf [Assessment Signed Date] Between([Prior Cycle Start Date];[Prior Cycle End Date]) Then "Y" Else "N" If [Assessment Type] ="Interim Report" Then DaysBetween([Complaint Initiated Date];[Assessment Signed Date]) If [Record Type]="Product Complaint" Then [Days Between Complaint Initiated and Prior Cycle Start]+45 Else [Days Between Complaint Initiated and Prior Cycle Start]+60
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
71 of 155
Variable Days Between Complaint Initiated and Prior Cycle Start Days Open As Of Report Date Days Past Due As Of Report Date Interim Report Number Of Cycles Open Unique Identifier vRisk
Purpose If [Interim Report Number Of Cycles Open]=1 Then 0 ElseIf [Interim Report Number Of Cycles Open]=2 Then 0 ElseIf [Record Type]="Product Complaint" Then ([Interim Report Number Of Cycles Open]-2) * 45 Else (([Interim Report Number Of Cycles Open]-3) * 45) + 60 DaysBetween([Complaint Initiated Date];ToDate(UserResponse("Enter Report Date:");"MM/dd/yyyy")) If ([Record Type]="Product Complaint") Then DaysBetween([Complaint Initiated Date];ToDate(UserResponse("Enter Report Date:");"MM/dd/yyyy")) 45 Else DaysBetween([Complaint Initiated Date];ToDate(UserResponse("Enter Report Date:");"MM/dd/yyyy")) - 60 Floor(If [Record Type]="Product Complaint" Then (([Days Open As Of Report Date]-45)/45 + 1) Else ([Days Open As Of Report Date]-60)/45 + 1) If([Complaint Number]=Previous([Complaint Number])) Then 0 Else 1 If Min([Risk])="?" Then "" Else Min([Risk]) Count([Complaint Number];All) (Count([Interim Report Present ?];All) Where ([Interim Report Present ?]="Y")/Count([Complaint Number];All)+Count([Interim Report On Time?];All) Where ([Interim Report On Time?]="Y")/Count([Complaint Number];All)+Count([vEsignOnTime];All) Where ([vEsignOnTime]="Y")/Count([Complaint Number];All))/3 Count([Interim Report Present ?];All) Where ([Interim Report Present ?]="Y")/Count([Complaint Number];All) Count([Interim Report On Time?];All) Where ([Interim Report On Time?]="Y")/Count([Complaint Number];All) Count([vEsignOnTime];All) Where ([vEsignOnTime]="Y")/Count([Complaint Number];All)
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
72 of 155
E. APPENDIX E - Open vs. Overdue Complaints Report Report Specification

E1 Main Report E1.1A Report Fields Vertical Stack Graph # 1
IO Site Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule X Axis Number Of Records Y Axis Ontime Open/OverDue Open Y Axis (Data Plotted) Record Type Complaint Initiated Year Complaint Initiated Quarter
For Review
Yes Dimensions/Complai nts/ComplaintsInvest igating Site/Dept/IO Site Measures/Complaint Measures/Number Of Complaints Custom Objects/ Complaint OverdueOntime Status
Yes Dimensions/Complai nts/ Record Type
Yes Dimensions/Complai nts/Complaints initiated Date/Complaint Initiated Year
Yes Dimensions/Complai nts/Complaints initiated Date/Complaint Initiated Quarter
Complaint Initiated Month Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule
Complaint Type
Yes Dimensions/Complai nts/Complaints initiated Date/Complaint Initiated Month
Yes Dimensions/Complai nts/ Complaint Type
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
73 of 155
E1.1B Cross Tab # 1

IO Site Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Column Ontime Open/OverDue Open Row Number Of Records Row Total Column Count Row
Hyperlink Dimensions/Complai nts/ComplaintsInvest igating Site/Dept/IO Site Custom Objects/ Complaint OverdueOntime Status Measures/Complaint Measures/Number Of Complaints
Hyperlink Report Variable
For Review
E1.1A Report Fields Vertical Stack Graph # 2

IO Site Number of Records OnTime-Open/ Overdue-Open,1-45 Days/ Overdue-Open, 4690 Days/ Overdue-Open, >90 Days Y Axis (Data Plotted) Record Type Complaint Initiated Year Complaint Initiated Quarter
X Axis
Y Axis
Yes Dimensions/Complai nts/ComplaintsInvest igating Site/Dept/IO Site Measures/Complaint Measures/Number Of Complaints Custom Objects/Complaints OverDue- Ontime Status(45/90)
Yes Dimensions/Complai nts/ Record Type
Yes Dimensions/Complai nts/Complaints initiated Date/Complaint Initiated Year
Yes Dimensions/Complai nts/Complaints initiated Date/Complaint Initiated Quarter
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
74 of 155
Complaint Initiated Month Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule
Complaint Type
Yes Dimensions/Complai nts/Complaints initiated Date/Complaint Initiated Month
Yes Dimensions/Complai nts/ Complaint Type
For Review
E1.1B Cross Tab # 2

IO Site OnTime-Open/ Overdue-Open,1-45 Days/ Overdue-Open, 4690 Days/ Overdue-Open, >90 Days Row Number Of Records Total Count
Column
Row
Column
Row
Hyperlink Dimensions/Complai nts/ComplaintsInvest igating Site/Dept/IO Site Custom Objects/Complaints OverDue- Ontime Status(45/90) Measures/Complaint Measures/Number Of Complaints
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
75 of 155
E1.2 Prompts Not applicable No prompts specified for this report. E1.3 Filter Conditions
Column/Filter Name Complaint Type Complaint Status Operator Not Equal To In List Value Clinical-Type 2 New;In Progress; Complaint Review Universe Object / Filter Dimensions/Complaints/Complaint Type Dimensions/Complaints/Complaint Status Notes Query Filter This report level filter should be applied to both the graphs and both the table
For Review
E1.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report. E1.5 Drill Up / Drill Down and Links
Drill/Link Name IO Site Number Of Records Total Count Drill Path / Link To IO Site -> IO Dept Complaints Drill Reports Complaints Drill Report Complaints Drill Report Description The link drills up from IO Site to IO Department The link passes IO Site, Complaint Status(Complaint Overdue-Ontime Status) and shows the Complaints Drill report for the Number of Records clicked on The link passes IO Site, Complaint Status(Complaint Overdue-Ontime Status) and shows the Complaints Drill report for the Number of Records clicked on The link passes IO Site, Complaint Status(Complaint Overdue-Ontime Status) and shows the Complaints Drill report for the Number of Records clicked on
E1.6 Security Requirements

Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
76 of 155
E1.7 Performance Requirements

E1.8 Print Requirements

Requirement Print View Description Each Tab should printed in One Page
E1.9 Query Design

For Review
E1.10 Report Variables Design

Variable Initiated Month Site vOpen OverDue Status vRecord Type Title Total Count Purpose Substr(Month([Complaint Initiated Month]);1;3) [IO Site] If [Record Type]="Product Complaint" And DaysBetween([Complaint Initiated Date];[Complaint Due Date (45 Days)])>45 Then "OverDue" ElseIf [Record Type]<>"Product Complaint" And DaysBetween([Complaint Initiated Date];[Complaint Due Date (45 Days)])>60 Then "OverDue" Else "Open" If DrillFilters([Complaint Record Type])="" Then "All Record Types" Else DrillFilters([Complaint Record Type]) Sum([Number of Complaints]) Sum([Number of Complaints])
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
77 of 155
E2 Data Table E2.1 Report Fields

Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule IO Site Row Ist Column Break Record Type Column 2nd Column Break Yes Hyperlink Dimensions/Complai nt/Complaint Investigating Site/Dept/IO Site Dimensions/Complai nts/Record Type Custom Objects/Complaints OverDue-OpenClose Status Measures/ Complaint Measures / Number of Complaints Hyperlink Sum(Number Of Complaints) Hyperlink Sum(Number Of Complaints) OverDue On Time Row # of Complaints Row Total Column Count Row
For Review
E2.2 Prompts Not applicable No prompts specified for this report. E2.3 Filter Conditions
Column/Filter Name Complaint Type Complaint Status Complaint OverdueOnTime Status(45/90) Operator Not Equal To In List Not Equal To Value Clinical-Type 2 New;In Progress; Complaint Review OnTime-Open Universe Object / Filter Dimensions/Complaints/Complaint Type Dimensions/Complaints/Complaint Status Custom Objects/Complaints OverDueOntime Status(45/90) Notes Query Filter This report level filter should be applied to the table This report level filter should be applied to the table
E2.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report.
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
78 of 155
E2.5 Drill Up / Drill Down and Links

Drill/Link Name # of Complaints Drill Path / Link To Complaints Drill Report Description The link passes IO Site, Complaint Status(Complaint Overdue-Ontime Status) and shows the Complaints Drill report for the Number of Records clicked on
E2.6 Security Requirements

E2.7 Performance Requirements

For Review
E2.8 Print Requirements

E2.9 Query Design

E2.10 Report Variables Design

Variable Initiated Month Site vOpen OverDue Status vRecord Type Title Total Count Purpose Substr(Month([Complaint Initiated Month]);1;3) [IO Site] If [Record Type]="Product Complaint" And DaysBetween([Complaint Initiated Date];[Complaint Due Date])>45 Then "OverDue" ElseIf [Record Type]<>"Product Complaint" And DaysBetween([Complaint Initiated Date];[Complaint Due Date])>60 Then "OverDue" Else "Open" If DrillFilters([Complaint Record Type])="" Then "All Record Types" Else DrillFilters([Complaint Record Type]) Sum([Number of Complaints]) Sum([Number of Complaints])
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
79 of 155
F. APPENDIX F - Overall Product Complaint/Issues Rates Report Report Specification

F1 CPM Report F1.1A Report Fields Line Graph # 1
Complaint Initiated Month X Axis CPM Y Axis Product Reported Report Name Data Plotted Complaint Initiated Year Complaint Initiated Quarter Complaint Type
For Review
Hyperlink Yes Dimensions/ Complaints / Complaint Initiated Date / Complaint Initiated Month Product Names Report Variable Dimesions/Complain ts/Product Reported/Product Reported Report Name Region
Yes Dimensions/ Complaints / Complaint Initiated Date / Complaint Initiated Year Record Type
Yes Dimensions/ Complaints / Complaint Initiated Date / Complaint Initiated Quarter
Yes Dimensions/ Complaints / Complaint Type
IO Site
Yes Report Variable
Yes Dimensions/Complai nts/Compliants Investigating Site/Dept/IO Site
Yes Dimensions/Distribut ion Quantity/Region
Yes Dimensions/ Complaints / Record Type
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
80 of 155
F1.1B Report Fields Cross tab # 1

Complaint Initiated Month Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Column Product Names (Enbrel Lyo/Enbrel PFS) Row CPM Data No. of Complaints Data
Hyperlink All Interactive Filters mentioned for Section R1A is applicable to this section Dimensions/ Complaints / Complaint Initiated Date / Complaint Initiated Month
Hyperlink
Dimesions/Complaints/Pro duct Reported/Product Reported Report Name
Report Variable
Measures/Complaint Measures/Number of Complaints
For Review
F1.1C Report Fields Line Graph # 2

Complaint Initiated Month CPM Product Names (All other Product Names except the one mentioned in filter [Row No:31]) Data Plotted
X Axis
Y Axis
Report Variable
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
81 of 155
F1.1D Report Fields Cross tab # 2

Complaint Initiated Month Product Names (All other Product Names except the one mentioned in filter [Row No:31]) Row CPM No. of Complaints
Position Section Sort Break Sub Total Format Interactive Report Filters
Column
Data
Data
Universe Class/Object or Variable Derived Rule
Hyperlink
For Review
Dimesions/Complaints/Pr oduct Reported/Product Reported Report Name
Report Variable
F1.1E Report Fields Line Graph # 3

Complaint Initiated Month Position Section Sort Break Sub Total Format Interactive Report Filters X Axis CPM Y Axis Product Names SureClick Aranesp/ SureClick Enbrel Data Plotted
Report Variable
Dimesions/Complaints/Product Reported/Product Reported Report Name
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
82 of 155
F1.1F Report Fields Cross tab # 3

Product Names SureClick Aranesp/ SureClick Enbrel Row
Complaint Initiated Month Column
CPM Data
No. of Complaints Data
Hyperlink
Dimensions/Complaints/P roduct/Product Name
Report Variable
For Review
F1.2 Prompts Not applicable No prompts specified for this report. F1.3 Filter Conditions
Column/Filter Name Product Reported Report Name Product Reported Report Name Product Reported Report Name Operator In List Not In List In List Value Enbrel Lyo; Enbrel PFS Universe Object / Filter Comments This filter should be applied to Section R1A and Section R1.1 A This filter should be applied to Section R1.2A and Section R1.2.1 A This filter should be applied to Section R1.3A and Section R1.3.1 A
Dimesions/Complaints/Product Reported/Product Reported Report Name Enbrel Lyo; Enbrel PFS; SureClick Dimesions/Complaints/Product Aranesp; SureClick Reported/Product Reported Report Name Enbrel;SureClick Neulasta;?;n/a SureClick Aranesp;SureClick Dimesions/Complaints/Product Enbrel Reported/Product Reported Report Name
F1.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report.
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
83 of 155
F1.5 Drill Up / Drill Down and Links

Drill/Link Name Complaint Initiated Month No. Of Complaints Drill Path / Link To Complaint Initiated Year -> Complaint InitiatedQuarter -> Complaint InitiatedMonth Complaints Drill Report Description The X-axis link in all the sections drills Up or Down from Complaint Intiated Year <-> Complaint Initiated Quarter <-> Complaint Initiated Month The link in all the sections shows the detail drill report for the No. of Complaints clicked on
F1.6 Security Requirements

For Review
F1.7 Performance Requirements

F1.8 Print Requirements

F1.9 Query Design

Query Production Volume Query Complaints Query Issues Query Purpose To get Production Volume values To get Complaint values To get Issue values
F1.10 Report Variables Design

Variable CPM Product Names Purpose If [Distribution Quantity]>0 Then Round(([Number of Complaints]/[Distribution Quantity])*1000000;0) Else 0 Production Volume. Product Reported Report Name
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
84 of 155
F2 CiPM Report F2.1A Report Fields Line Graph # 1

Complaint Initiated Month X Axis CiPM Y Axis Product Reported Report Name Data Plotted Complaint Initiated Year Complaint Initiated Quarter Complaint Type
Hyperlink Yes Dimensions/ Complaints / Complaint Initiated Date / Complaint Initiated Month Product Names Report Variable Dimesions/Complain ts/Product Reported/Product Reported Report Name Region
Yes Dimensions/ Complaints / Complaint Initiated Date / Complaint Initiated Year Record Type
Yes Dimensions/ Complaints / Complaint Initiated Date / Complaint Initiated Quarter
Yes Dimensions/ Complaints / Complaint Type
For Review
IO Site
Yes Report Variable
Yes Dimensions/Complai nts/Compliants Investigating Site/Dept/IO Site
Yes Dimensions/Distribut ion Quantity/Region
Yes Dimensions/ Complaints / Record Type
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
85 of 155
F2.1B Report Fields Cross Tab #

Complaint Initiated Month Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Column Product Names (Enbrel Lyo/Enbrel PFS) Row CiPM Data No. of Complaints Data
Hyperlink
Dimensions/Complaints/Pr oduct Reported/Product Reported Report Name
Report Variable
For Review
F2.1C Report Fields Line Graph # 2

Complaint Initiated Month CiPM Product Names (All other Product Names except the one mentioned in filter [Row No:31]) Data Plotted
X Axis
Y Axis
Drill up/down All Interactive Filters mentioned for Section R1A is applicable to this section Dimensions/ Complaints / Complaint Initiated Date / Complaint Initiated Month
Report Variable
Dimesions/Complaints/P roduct Reported/Product Reported Report Name
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
86 of 155
F2.1B Report Fields Cross Tab # 2

Complaint Initiated Month Product Names (All other Product Names except the one mentioned in filter [Row No:31]) Row CiPM No. of Complaints
Column
Data
Data
Hyperlink
For Review
Report Variable
F2.1E Report Fields Line Graph # 3

Complaint Initiated Month Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule X Axis CiPM Y Axis Product Names SureClick Aranesp/ SureClick Enbrel Data Plotted
Report Variable
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
87 of 155
F2.1B Report Fields Cross Tab # 3

Complaint Initiated Month Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Column Product Names SureClick Aranesp/ SureClick Enbrel Row CiPM Data No. of Complaints Data
Hyperlink
Dimensions/Complaints/ Product/Product Name
Report Variable
For Review
F2.2 Prompts Not applicable No prompts specified for this report. F2.3 Filter Conditions
Column/Filter Name Product Reported Report Name Product Reported Report Name Operator In List Not In List Value Enbrel Lyo; Enbrel PFS Enbrel Lyo; Enbrel PFS; SureClick Aranesp; SureClick Enbrel;SureClick Neulasta;?;n/a SureClick Aranesp;SureClick Enbrel Universe Object / Filter Dimesions/Complaints/Produc t Reported/Product Reported Report Name Dimesions/Complaints/Produc t Reported/Product Reported Report Name Dimesions/Complaints/Produc t Reported/Product Reported Report Name Comments This filter should be applied to Section R1A and Section R1.1 A This filter should be applied to Section R1.2A and Section R1.2.1 A
Product Reported Report Name
In List
This filter should be applied to Section R1.3A and Section R1.3.1 A
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
88 of 155
F2.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report. F2.5 Drill Up / Drill Down and Links
Drill/Link Name Complaint Initiated Month Drill Path / Link To Complaint Initiated Year -> Complaint InitiatedQuarter -> Complaint InitiatedMonth Complaints Drill Report Description The X-axis link in all the sections drills Up or Down from Complaint Intiated Year <-> Complaint Initiated Quarter <-> Complaint Initiated Month
No. Of Complaints
The link in all the sections shows the detail drill report for the No. of Complaints clicked on
For Review
F2.6 Security Requirements

F2.7 Performance Requirements

F2.8 Print Requirements

F2.9 Query Design

Query Production Volume Query Complaints Query Issues Query Purpose To get Production Volume values To get Complaint values To get Issue values
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
89 of 155
F2.10 Report Variables Design

Variable Product Names CiPM Purpose Production Volume. Product Reported Report Name If [Distribution Quantity]>0 Then Round(([Number of Complaints]/[Distribution Quantity])*1000000;0) Else 0
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
90 of 155
G.
APPENDIX G - Top Product Complaint Cause Codes by Product Report Report Specification
G1 Main Page G1.1A Report Fields Line Graph

Complaint Initiated Month X Axis CiPM Y Axis Cause Code Data Plotted Yes Complaint Initiated Quarter Complaint Initiated Year IOSite Product Name
For Review
Yes Dimensions/Co mplaints/Compla ints initiated Date/Complaint Initiated Month Report Variable Dimensions/iss ues/Cause Code Dimensions/Co mplaints/Compla ints initiated Date/Complaint Initiated Quarter Dimensions/Compl aints/Complaints initiated Date/Complaint Initiated Year Dimensions/ CiPM Dimensions/I O Site
Yes (Merged Dimension) Dimensions/ Complaints /Product Reported/Product Reported Report Name(Issues Query) Dimensions/ Complaints /Product Reported/ Product Reported Report Name (Production Volume Query)
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
91 of 155
G1.1B Report Fields Cross Table

Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Producat Name Row Cause Code Row Rank Column Ascending Hyperlink All interactive filters metioned in R1A is applicable here All interactive filters metioned in R1A is applicable here Dimensions/issues /Cause Code [Ranked Production] Issues Column CiPM Column Distribution Column Risk Column Baseline Column
For Review
[Rank]
[Ranked Issues]
[Ranked CiPM]
[Baseline Risk]
[Max Baseline]
G1.2 Prompts
Prompt order 1 Description CiPM Month Display Text Enter Starting Month Enter Ending Month Enter Ranking Month: Operator Greater Than or Equal to Required/ Optional Optional Single/Multi Single Type String Default Values Comments Query: Combined Query 2 of the Issue Analysis Data and Combined Query 3 of Production Analysis Data. Query: Combined Query 2 of the Issue Analysis Data and Combined Query 3 of Production Analysis Data. Query: Combined Query 2 of the Issue Analysis Data and Combined Query 3 of Production Analysis Data. Query: Issue Analysis Data Combined Query 1 and Combined Query 2 of Union Queries
CiPM Month
Less Than or Equal to
Optional
Single
String
CiPM Month
Equal To (In Combined Query 1) / Not Equal To (In Combined Query 2) of Issue Analysis Data. Equal To (In Combined Query 2) / Not Equal To (In Combined Query 3) of Production Analysis Data Equal To (In Combined Query 1) / Not Equal To (In Combined Query 2) of Issue Analysis Data. Equal To (In Combined Query 2) / Not Equal To (In Combined Query 3) of Production Analysis Data
Optional
Single
String
CiPM Quarter
Enter Ranking Quarter
Optional
Single
String
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
92 of 155
CiPM Year
Enter Ranking Year
Equal To (In Combined Query 1) / Not Equal To (In Combined Query 2) of Issue Analysis Data. Equal To (In Combined Query 2) / Not Equal To (In Combined Query 3) of Production Analysis Data
Optional
Single
String
Query: Issue Analysis Data Combined Query 1 and Combined Query 2 of Union Queries
G1.3 Filter Conditions

Column/Filter Name Rank Production Volume Measure Cause Code Operator Less Than or Equal To Is Not Null Not In List Value 5 Universe Object / Filter Report Variable Measures/CiPM Measures/Production Volume Measure Dimensions/Issues/Cause Code Comments Applies to both Sections R1A and R1B This is part of Pre-Set Filters. This is for all the queries in Issue Analysis Data and Production Analysis Data. This is part of Pre-Set Filters and for both combined queries of Issue Analysis Data
For Review
Cause Code Where (Cause Code In List "?;Void") And (Issue Count Measure=0 Or Issue Count Measure Is Null) EURO ATO Australia ELC
IO Site Region IO Site Region IO Site
Is Not Null Not Equal to Not Equal to Not Equal to Not Equal to
Dimensions/CiPM Dimensions/IO Site Dimensions/CiPM Dimensions/Region Dimensions/CiPM Dimensions/IO Site Dimensions/CiPM Dimensions/Region Dimensions/CiPM Dimensions/IO Site
(And) For both combined queries of Production Analysis Data (Or) For both combined queries of Production Analysis Data (Or) For both combined queries of Production Analysis Data
G1.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report.
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
93 of 155
G1.5 Drill Up / Drill Down and Links

Drill/Link Name Issues Drill Path / Link To Isssues Drill Report Description "<a href=\"../../opendoc/openDocument.jsp?iDocID=AQy3YP7LxEpJqYRW5_T1gbg&sIDType=CUID&sType=wid&lsSEnter%20Caus e%20Code%3A="+URLEncode(""+[Cause Code])+"&lsSEnter%20Complaint%20Initiated%20Month%3A="+URLEncode(UserResponse([Issues Query]; "Enter Ranking Month:"))+"&lsSEnter%20Complaint%20Initiated%20Quarter%3A="+URLEncode(UserResponse([Issues Query]; "Enter Ranking Quarter:"))+"&lsSEnter%20Complaint%20Initiated%20Year%3A="+URLEncode(UserResponse([Issues Query]; "Enter Ranking Year:"))+"&lsSEnter%20Product%20Reported%20Report%20Name%3A="+URLEncode(""+[Product Name])+"&lsSEnter%20Complaint%20Type%3A=Commercial&lsSEnter%20Record%20Type%3A=Product%20Complaint&lsSE nter%20Issue%20Included%20Flag%3A=1&sWindow=New\" title=\"\" target=\"_self\" nav=\"doc\">"+[Ranked Issues]+"</a>"
For Review
G1,6 Security Requirements

G1.7 Performance Requirements

G1.8 Print Requirements

G1.9 Query Design

Query Issues Query Production Volume Query Purpose Main Query Query
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
94 of 155
G1.10 Report Variables Design

Variable Complaint Initiated Date Data Set Ranking Period All Issues Baseline Risk CiPM Max Baseline Production Rank Ranked CiPM Ranked Issues Ranked Production Ranking Period Link Variable Purpose If(UserResponse([Issues Analysis Data]; "3: Enter Ranking Month:") > "0"; [Complaint Initiated Month]; If(UserResponse([Issues Analysis Data]; "4: Enter Ranking Quarter:") > "0"; [Complaint Initiated Quarter]; [Complaint Initiated Year])) [Rank - Ranked Data] UserResponse([Issues Query]; "Enter Ranking Month:") + UserResponse([Issues Query]; "Enter Ranking Year:") + UserResponse([Issues Query]; "Enter Ranking Quarter:") Sum([Number of Issues]) ForAll ([Data Set]) If [Max Baseline] = 500 Then "Minor" ElseIf [Max Baseline] = 100 Then "Major B" ElseIf [Max Baseline] = 50 Then "Major A" ElseIf [Max Baseline] = 5 Then "Critical" Else "N/A" If([Production] > 0) Then ([All Issues]/[Production]*1000000) Else 0 Max([Lot Check Baseline Rt]) Sum([Distribution Quantity]) ForAll ([Data Set]) Rank([Ranked Issues];[Cause Code];Top) Where ([Data Set] = "Ranking Data") ForAll ([Complaint Initiated Month]) [Ranked Issues] / [Ranked Production] * 1000000 Sum([Number of Issues]) Where ([Data Set] = "Ranking Data") [Distribution Quantity] Where ([Data Set] = "Ranking Data") If(Sum([Issue Count Measure]) Where ([Data Set] = "Ranking Data") = 0; "Please Check Date Parameters"; If(UserResponse([Issues Analysis Data]; "3: Enter Ranking Month:") > "0"; UserResponse([Issues Analysis Data]; "3: Enter Ranking Month:"); If(UserResponse([Issues Analysis Data]; "4: Enter Ranking Quarter:") > "0"; UserResponse([Issues Analysis Data]; "4: Enter Ranking Quarter:"); If(UserResponse([Issues Analysis Data]; "5: Enter Ranking Year:") > "0"; UserResponse([Issues Analysis Data]; "5: Enter Ranking Year:")))))
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
95 of 155
G2 Data Table G2.1 Report Fields

Complaint Initiated Date (CiPM Month/CiPM Quarter/CiPM Year) Column Rank Issues CiPM Distribution Risk
Column/Data Ascending
Column/Data
Column/Data
Column/Data
Column/Data
Yes Dimensions/ CiPM Dimensions/ (CiPM Month/CiPM Quarter/CiPM Year) Baseline Column/Data [Rank] [All Issues] [CiPM] [Production] [Baseline Risk]
For Review
Product Name Row Yes
Cause Code Row
Baseline Risk Row
Max Baseline Row
[Max Baseline]
(Merged Dimension) Dimensions/ Complaints /Product Reported/Product Reported Report Name(Issues Query) Dimensions/ Complaints /Product Reported/ Product Reported Report Name (Production Volume Query)
Dimensions/issues/C ause Code
[Baseline Risk]
[Max Baseline]
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
96 of 155
G2.2 Prompts
Prompt order Description CiPM Month CiPM Month 1 CiPM Month Display Text Enter Starting Month Enter Ending Month Enter Ranking Month: Operator Greater Than or Equal to Less Than or Equal to Equal To (In Combined Query 1) / Not Equal To (In Combined Query 2) of Issue Analysis Data. Equal To (In Combined Query 2) / Not Equal To (In Combined Query 3) of Production Analysis Data Equal To (In Combined Query 1) / Not Equal To (In Combined Query 2) of Issue Analysis Data. Equal To (In Combined Query 2) / Not Equal To (In Combined Query 3) of Production Analysis Data Equal To (In Combined Query 1) / Not Equal To (In Combined Query 2) of Issue Analysis Data. Equal To (In Combined Query 2) / Not Equal To (In Combined Query 3) of Production Analysis Data Required/ Optional Optional Optional Optional Single/Multi Single Single Single Type String String String Query: Combined Query 2 of the Issue Analysis Data and Combined Query 3 of Production Analysis Data. Query: Issue Analysis Data Combined Query 1 and Combined Query 2 of Union Queries Query: Issue Analysis Data Combined Query 1 and Combined Query 2 of Union Queries Default Values Comments
For Review
CiPM Quarter
Enter Ranking Quarter
Optional
Single
String
CiPM Year
Enter Ranking Year
Optional
Single
String
G2.3 Filter Conditions

Column/Filter Name Rank Production Volume Measure Operator Less Than or Equal To Is Not Null Value 5 Universe Object / Filter Report Variable Measures/CiPM Measures/Production Volume Measure Comments This is part of Pre-Set Filters. This is for all the queries in Issue Analysis Data and Production Analysis Data.
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
97 of 155
Cause Code
Not In List
Cause Code Where (Cause Code In List "?;Void") And (Issue Count Measure=0 Or Issue Count Measure Is Null) EURO ATO Australia ELC
Dimensions/Issues/Cau se Code
This is part of Pre-Set Filters and for both combined queries of Issue Analysis Data
IO Site Region IO Site Region IO Site
Is Not Null Not Equal to Not Equal to Not Equal to Not Equal to
Dimensions/CiPM Dimensions/IO Site Dimensions/CiPM Dimensions/Region Dimensions/CiPM Dimensions/IO Site Dimensions/CiPM Dimensions/Region Dimensions/CiPM Dimensions/IO Site
(And) For both combined queries of Production Analysis Data (Or) For both combined queries of Production Analysis Data
(Or) For both combined queries of Production Analysis Data
For Review
G2.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report. G2.5 Drill Up / Drill Down and Links Not applicable No drill up / drill down or links specified for this report. G2,6 Security Requirements
G2.7 Performance Requirements

Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
98 of 155
G2.8 Print Requirements

G2.9 Query Design

Query Issues Query Production Volume Query Purpose Main Query Query
For Review
G2.10 Report Variables Design

Variable Data Set Ranking Period All Issues Baseline Risk CiPM Max Baseline Production Rank Ranked CiPM Ranked Issues Ranked Production Complaint Initiated Date Purpose [Rank - Ranked Data] UserResponse([Issues Query]; "Enter Ranking Month:") + UserResponse([Issues Query]; "Enter Ranking Year:") + UserResponse([Issues Query]; "Enter Ranking Quarter:") Sum([Number of Issues]) ForAll ([Data Set]) If [Max Baseline] = 500 Then "Minor" ElseIf [Max Baseline] = 100 Then "Major B" ElseIf [Max Baseline] = 50 Then "Major A" ElseIf [Max Baseline] = 5 Then "Critical" Else "N/A" If([Production] > 0) Then ([All Issues]/[Production]*1000000) Else 0 Max([Lot Check Baseline Rt]) Sum([Distribution Quantity]) ForAll ([Data Set]) Rank([Ranked Issues];[Cause Code];Top) Where ([Data Set] = "Ranking Data") ForAll ([Complaint Initiated Month]) [Ranked Issues] / [Ranked Production] * 1000000 Sum([Number of Issues]) Where ([Data Set] = "Ranking Data") [Distribution Quantity] Where ([Data Set] = "Ranking Data") If(UserResponse([Issues Analysis Data]; "3: Enter Ranking Month:") > "0"; [Complaint Initiated Month]; If(UserResponse([Issues Analysis Data]; "4: Enter Ranking Quarter:") > "0"; [Complaint Initiated Quarter]; [Complaint Initiated Year]))
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
99 of 155
H. APPENDIX H - Site/Partner Performance in Complaint Assessments Management Report Report Specification

H1A Vertical Bar Graph # 1
Assessor Site Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule X Axis Amgen X Axis % of Amgen Assessments Y - Axis, Data Plotted Assessor Name Complaint Type
For Review
Yes Dimensions/Assess ments/Assessor/Ass essor Site Dimensions/Assess ments/Assessor/Am gen / NonAmgen Site Report Variable
Yes Dimensions/Assess ments/Assessor/Ass essor Name
Yes Dimensions/Complai nts/Complaint Type
IO Site Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule
Investigation Level
Record Type
Assessment Due Year
Assessment Due Quarter
Assessment Due Month
Yes Dimensions/Complai nts/Complaint Investigating Site/Dept/ IO Site
Yes Dimensions/Complai nts/Investigation Level
Yes
Dimensions/Complai nts/Record Type
Yes Dimensions/Assess ments/ Assessment Due Date / Assessment Due Year
Yes Dimensions/Assess ments/ Assessment Due Date / Assessment Due Quarter
Yes Dimensions/Assess ments/ Assessment Due Date / Assessment Due Month
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
100 of 155
Product Reported Product Name Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule
Delivery System
Assessment Type
Yes Dimesions/Complain ts/Product Reported/Product Reported Report Name
Yes Dimensions/Assess ments/Assessments Type
For Review
H1B Pivot Table # 1

Amgen Assessment Site Column On Time Row Total # due Row Total Column
Hyperlink All Filters mentioned in Section R1 A is applicable to this section Dimensions/Assess ments/Assessor/Ass essor Site
Report Variable
Report Variable
Sum(On Time), Sum(Total# due)
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
101 of 155
H1C Vertical Bar Graph # 2

Assessor Site Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule X Axis Non-Amgen X Axis % of Amgen Assessments Y Axis (Data Plotted)
All Filters mentioned in Section R1 A is applicable to this section Dimensions/Assess ments/Assessor/Ass essor Site
Dimensions/Assess ments/Assessor/(Am gen / Non-Amgen)
Report Variable
For Review
H1D Pivot Table # 2

Non-Amgen Assessment Site Column On Time Row Total # due Row Total Column
Hyperlink All Filters mentioned in Section R1 A is applicable to this section Dimensions/Assess ments/Assessor/Ass essor Site
Report Variable
Report Variable
Sum(On Time), Sum(Total# due)
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
102 of 155
H2 Prompts
Prompt order 1 2 Description Assessment Due Date Assessment Due Date Display Text Enter Assessment Due Date (Start): Enter Assessment Due Date (End): Operator Between Required/ Optional Required Required Single/Multi Single Single Type Date Date Default Values None None
H3 Filter Conditions
Column/Filter Name Assessment Status Assessor Site Operator Not Equal To Not In List Value Voided N/A;Void;ACO Reference;AML Reference;ARI Reference;ATO Reference;Baxter Reference;BD Reference;BI Pharma Reference;Bioject - Reference;Cardinal Reference;DSM Reference;ELC Reference;Genentech Reference;Patheon Reference;Precise reference;Becton Dickinson Ref;Vetter Pharma Ref Amgen Non-Amgen Universe Object / Filter Dimensions/Assessments/Assessment Status Dimensions/Assessments/Assessor/Assessor Site
For Review
Amgen/NonAmgen Site Amgen/NonAmgen Site
In List In List
Dimensions/Assessments/Assessor/Amgen / NonAmgen Site Dimensions/Assessments/Assessor/Amgen / NonAmgen Site
H4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report. H5 Drill Up / Drill Down and Links
Drill/Link Name Total # Due Total # Due Drill Path / Link To Assessments Drill Report Assessments Drill Report Description This is a drill through to Assessments Drill Report for Amgen Sites This is a drill through to Assessments Drill Report for NonAmgen Sites Comments Section 1.1 R Section 1.3 R
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
103 of 155
H6 Security Requirements
H7 Performance Requirements
For Review
H8 Print Requirements
H9 Query Design
Query Site Partner Query Purpose To get report values
H10 Report Variables Design

Variable Date Range End Date Range Start vLagOpenedToClosed AmgenPct NonAmgenPct PromptDisplayEndDate PromptDisplayStartDate SelectedFilters vCountAssessmentsDue vCount Assmt No Purpose ToDate(UserResponse("Enter Assessment Due Date(End):");"MM/dd/yyyy") ToDate(UserResponse("Enter Assessment Due Date(Start):");"MM/dd/yyyy") [Assessment Lag Opened To Closed] If[Amgen / NonAmgen Site]="Amgen" Then [vOntime]/[vCountAssessmentsDue] Else 0 If [Amgen / NonAmgen Site]="Non-Amgen" Then ([vOntime]/[vCountAssessmentsDue] ) Else 0 "Assessment Due Date(End) :"+" "+UserResponse("Enter Assessment Due Date(End):") "Assessment Due Date(Start) :"+" "+UserResponse("Enter Assessment Due Date(Start):") If DrillFilters()="" Then "None" Else DrillFilters(" / ") Count([Assessment Number]) Count([Assessment Number])
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
104 of 155
Variable vOntime vOverdue
Purpose Count([Assessment Number]) Where (DaysBetween([Assessment Open Date];[Assessment Completed Date])<[Assessment Target Days To Close] Or DaysBetween([Assessment Open Date];[Date Range End])<[Assessment Target Days To Close]) Count([Assessment Number]) Where (If Not(IsNull([Assessment Completed Date])) Then DaysBetween([Assessment Open Date];[Assessment Completed Date])>[Assessment Target Days To Close] Else DaysBetween([Assessment Open Date];CurrentDate())>[Assessment Target Days To Close])
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
105 of 155
I. APPENDIX I - Periodic Product Complaint Excursion Report Report Specification

I1 Summary Report Tab # 1 Trending Working Analysis I1.1 Report Fields Header:
Analysis Month Start Month [Period 1] Min([Compla int Initiated Month]) End Month [Period 1] Formatting Legend Number of Months Analyzed Black Bold = Any Sigma Violation Green Bold = Below Baseline Red Bold = Above Listed Sigma Value "Number of Months Analyzed: " + (MonthsBetween(Min([CiPM Date]);Max([CiPM Date]))+1) + " Months"
For Review
Table:
Product - Item Type - Cause Code Row Product Row Issue Item Type Row Cause Code Row Risk Row Baseline Rate Row
Yes [Issue Concatenated] [Product Reported Report Name]
Yes [Issue Display Item Type]
Yes Dimensions/Issues/ Cause Code If [Max Baseline] = 500 Then "Minor" ElseIf [Max Baseline] = 100 Then "Major B" ElseIf [Max Baseline] = 50 Then "Major A" ElseIf [Max Baseline] = 5 Then "Critical" Else "N/A" [Max Baseline]
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
106 of 155
CiPM Month Column/Data Desc
Distribution Column/Data
Issues Column/Data
CiPM Column/Data
Baseline Column/Data
Column/Data
Yes Dimensions/CiPM Dimensions/CiPM Dates/CiPM Month NoFilter([Distribution Quantity]; All)
Hyperlink [Issue Quantity Included] NoFilter([CiPM]; All) NoFilter([Baseline Measure] * 1000000; All) NoFilter([Below Baseline]; All)
For Review
1 Sigma Column/Data
Column/Data
2 Sigma Column/Data
Column/Data
3 Sigma Column/Data
Column/Data
NoFilter([1 Sigma]; All)
NoFilter([1 Sigma Violation]; All)
NoFilter([2 Sigma Violation];All)
NoFilter([3 Sigma Violation]; All)
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
107 of 155
Totals 1 Sig Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule
2 Sig
3 Sig
BL
[1 Sigma Total]
[2 Sigma Total]
[3 Sigma Total]
[Baseline Total (9 Below)]
For Review
I1.2 Prompts
Description Operator Display Text Enter Starting Analysis Month CiPM Month Between Enter Ending Analysis Month Required/ Optional Optional Required Single/Multi Single Single Type Date Date Default Values Applies To Complaint Initiated Month & Distribution Quantity Month Complaint Initiated Month & Distribution Quantity Month
I1.3 Filter Conditions

Column/Filter Name Baseline Measure Baseline Operator Greater Than Greater Than Or Equal To Value 0 0 Universe Object / Filter Measures/CiPM Measures/Baseline Measure [Baseline] Comments This is a Pre-set Filter This is a Pre-set Filter
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
108 of 155
I1.4 Alerts and Conditional Formatting

Alerter Name 3 Sigma 2 Sigma 1 Sigma Any Sigma Violation Below Baseline 1 Sigma Total 2 Sigma Total 3 Sigma Total Baseline Total Baseline Rate CiPM Null Purpose if CiPM > 3 Sigma then display the contents of the cell in Red if CiPM > 2 Sigma then display the contents of the cell in Red if CiPM > 1 Sigma then display the contents of the cell in Red if CiPM > 3 Sigma then display the contents of the cell in Black OR if CiPM > 2 Sigma then display the contents of the cell in Black OR if CiPM > 1 Sigma then display the contents of the cell in Black if CiPM < Baseline then display the contents of the cell in Green if I Sigma Total >= 4 then display the contents of the cell in Red if 2 Sigma Total >= 2 then display the contents of the cell in Red if 3 Sigma Total >= 1 then display the contents of the cell in Red if Baseline Total (9 Below) >=9 then display the contents of the cell in Green if CiPM > Max Baseline then display the contents of the cell in Red if CiPM Is Null then display the contents of the cell in Green Applies To Column 3 Sigma 2 Sigma 1 Sigma CiPM Baseline 1 Sig 2 Sig 3 Sig BL
For Review
I1.5 Drill Up / Drill Down and Links

Drill/Link Name Issues Drill Path / Link To Issue Drill Report Description This link opens a new window with a detailed issue report for the selection made
I1.6 Security Requirements

I1.7 Performance Requirements

Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
109 of 155
I1.8 Print Requirements

Requirement Print View Description Each Tab should be printed in one page
I1.9 Query Design

Query Issues Distribution Baseline Purpose Main Query Main Query Main Query
I1.10 Report Variables Design

Variable Baseline Rate Violation Flag Issue Concatenated 0 Sigma 1 Sigma 1 Sigma Total 1 Sigma Violation 2 Sigma 2 Sigma Total 2 Sigma Violation 3 Sigma 3 Sigma Total 3 Sigma Violation Baseline Baseline Rate Total Baseline Rate Violation Baseline Total (9 Below) Below Baseline CiPM Max Baseline Period 1 Period 1 Month Period 1 Year Purpose If [Baseline Rate Violation] = 1Then "Violation" Else "" [Product Reported Report Name] + " - " + [Issue Display Item Type] + " - " + [Cause Code] If ([Distribution Quantity] = 0) Then 0 Else ([Baseline Measure] / [Distribution Quantity]) (Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000 Sum([1 Sigma Violation]) Where ([Complaint Initiated Month] Between ([Period 5]; [Period 1])) If [CiPM] > [1 Sigma] Then 1 Else 0 (2*Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000 Sum([2 Sigma Violation]) Where ([Complaint Initiated Month] Between ([Period 3]; [Period 1])) ForEach ([Product Reported Report Name]; [Issue Item Type]; [Cause Code]) ForAll ([Complaint Initiated Month]) If [CiPM] > [2 Sigma] Then 1 Else 0 (3*Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000 Sum([3 Sigma Violation]) Where ([Complaint Initiated Month] = [Period 1]) If [CiPM] > [3 Sigma] Then 1 Else 0 [Baseline Measure] * 1000000 [Baseline Rate Violation] Where ([Complaint Initiated Month] = [Period 1]) If [CiPM] > Max([Lot Check Baseline Rt]) Then 1 Else 0 Sum([Below Baseline]) Where ([Complaint Initiated Month] Between ([Period 9]; [Period 1])) If [CiPM] < [Baseline Measure] * 1000000 Then 1 Else 0 [Issue Quantity Included] / [Distribution Quantity] * 1000000 Max([Baseline Rate]) Max([Distribution Quantity Month]) In Block ToNumber(Substr([Period 1]; 6; 2)) ToNumber(Substr([Period 1]; 1; 4))
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
110 of 155
Variable Period 3 Period 5 Period 9 Distribution Issue Count Period 2 Period 4 Period 6 Period 7 Period 8
Purpose If [Period 1 Month] > 2 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 2; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 10; "0#") If [Period 1 Month] > 4 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 4; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 8; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 8; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 4; "0#") NoFilter([Production Volume Measure]; All) If IsNull([Issue Count Measure]) Then 0 Else [Issue Count Measure] If [Period 1 Month] > 2 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 1; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 11; "0#") If [Period 1 Month] > 4 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 3; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 9; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 5; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 7; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 6; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 6; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 7; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 5; "0#")
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
111 of 155
I2 Summary Report Tab # 2 Tab TrendingWorkingPresentationByGroup I2.1 Report Fields Header:

Analysis Month Start Month [Period 1] Min([Com plaint Initiated Month]) End Month [Period 1] Number of Months Analyzed "Number of Months Analyzed: " + (MonthsBetween(Min([CiPM Date]);Max([CiPM Date]))+1) + " Months"
Table:
For Review
Yes Dimensions/Issues/ Cause Code If [Max Baseline] = 500 Then "Minor" ElseIf [Max Baseline] = 100 Then "Major B" ElseIf [Max Baseline] = 50 Then "Major A" ElseIf [Max Baseline] = 5 Then "Critical" Else "N/A" [Max Baseline]
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
112 of 155
Issues Column/Data
CiPM Column/Data
1 Sigma Column/Data
2 Sigma Column/Data
Hyperlink Yes Dimensions/CiPM Dimensions/CiPM Dates/CiPM Month NoFilter([Distribu tion Quantity]; All) [Issue Quantity Included] NoFilter([CiPM] ; All) NoFilter([Baseline Measure] * 1000000; All) NoFilter([1 Sigma]; All) NoFilter([2 Sigma]; All)
For Review
3 Sigma Column/Data Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule
Totals 1 Sig 2 Sig 3 Sig BL
NoFilter([3 Sigma]; All) [1 Sigma Total] [2 Sigma Total] [3 Sigma Total] [Baseline Total (9 Below)]
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
113 of 155
I2.1.1 Cross Tab
2 Sigma Violations Product - Item Type - Cause Code Row
Product Row
Issue Item Type Row
Cause Code Row
Risk Row
Baseline Rate Row
[Issue Concatenated]
Yes [Product Reported Report Name]
Yes Dimensions/Is sues/Cause Code
If [Max Baseline] = 500 Then "Minor" ElseIf [Max Baseline] = 100 Then "Major B" ElseIf [Max Baseline] = 50 Then "Major A" ElseIf [Max Baseline] = 5 Then "Critical" Else "N/A"
[Max Baseline]
Yes Dimensions/CiPM Dimensions/CiPM Dates/CiPM Month
For Review
Distribution Position Section Sort Break Sub Total Format Interactive Report Filters Column/Data
Issues Column/ Data
CiPM Column/ Data
Baseline Column/ Data Column/ Data
1 Sigma Column/ Data Column/ Data
Hyperlink
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
114 of 155
NoFilter([Pro duction Volume Measure]; All)
[Issue Count]
[CiPM]
NoFilter([ Baseline Measure] * 1000000; All)
[Below Baseline]
[1 Sigma]
[1 Sigma Violation]
[2 Sigma]
[2 Sigma Violation]
[3 Sigma]
[3 Sigma Violation]
Totals Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule 1 Sig 2 Sig 3 Sig BL
For Review
[1 Sigma Total]
[2 Sigma Total]
[3 Sigma Total]
I2.1.2 Cross Tab

1 Sigma Violations Product - Item Type Cause Code Position Section Sort Break Sub Total Format Interactive Report Filters Row
Product Row
Issue Item Type Row
Cause Code Row
Risk Row
Baseline Rate Row
Yes
Yes
Yes
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
115 of 155
[Product Reported Report Name]
[Issue Display Item Type]
Dimensions/Issues/Ca use Code
[Max Baseline]
CiPM Month Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Column/Data Desc
Issues Column/Data
CiPM Column/Data Column/Data
1 Sigma Column/Data Column/Data
For Review
Hyperlink NoFilter([Baseline Measure] * 1000000; All)
NoFilter([Production Volume Measure]; All)
[Issue Count]
[CiPM]
[Below Baseline]
[1 Sigma]
[1 Sigma Violation]
2 Sigma Position Section Column/Data Column/Data
1 Sig
2 Sig
Totals 3 Sig
BL
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
116 of 155
Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule
[2 Sigma]
[2 Sigma Violation]
[3 Sigma]
[3 Sigma Violation]
[1 Sigma Total]
[2 Sigma Total]
[3 Sigma Total]
For Review
I2.1.3 Cross Tab

9 Consecutive Below Baseline Product - Item Type Cause Code Row
Product Row
Issue Item Type Row
Cause Code Row
Risk Row
Baseline Rate Row
Yes [Product Reported Report Name]
Yes
Yes If [Max Baseline] = 500 Then "Minor" ElseIf [Max Baseline] = 100 Then "Major B" ElseIf [Max Baseline] = 50 Then "Major A" ElseIf [Max Baseline] = 5 Then "Critical" Else "N/A"
Dimensions/Issues/C ause Code
[Max Baseline]
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
117 of 155
Issues Column/Data
CiPM Column/Data
Baseline Column/Data Column/Data
Hyperlink NoFilter([Production Volume Measure]; All) [Issue Count] NoFilter([Baseline Measure] * 1000000; All) [Below Baseline] [1 Sigma Violation]
[CiPM]
[1 Sigma]
For Review
1 Sig
2 Sig
Totals 3 Sig
BL
[2 Sigma]
[2 Sigma Violation]
[3 Sigma]
[3 Sigma Violation]
[1 Sigma Total]
[2 Sigma Total]
[3 Sigma Total]
I2.2 Prompts
Description CiPM Month Operator Display Text Enter Starting Analysis Month Between Enter Ending Analysis Month Required/ Optional Optional Required Single/Multi Single Single Type Date Date Default Values Applies To Dimensions/CiPM Dimensions/CiPM Dates/CiPM Month Dimensions/CiPM Dimensions/CiPM Dates/CiPM Month
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
118 of 155
I2.3.1 Filter Conditions 3 Sigma Violations
Column/Filter Name Baseline Baseline Measure 3 Sigma Total
Operator Greater Than Or Equal To Greater Than Greater Than Or Equal To
Value 0 0 1
Universe Object / Filter [Baseline] Measures/CiPM Measures/Baseline Measure [3 Sigma Total]
Comments This is a Pre-set Filter and This is a block filter This is a Pre-set Filter and This is a block filter This is a Pre-set Filter and This is a block filter

Column/Filter Name Baseline Baseline Measure 2 Sigma Total
For Review
Operator Greater Than Or Equal To Greater Than Greater Than Or Equal To
Value 0 0 2
Universe Object / Filter [Baseline] Measures/CiPM Measures/Baseline Measure [2 Sigma Total]
Comments This is a Pre-set Filter and This is a block filter This is a Pre-set Filter and This is a block filter This is a Pre-set Filter and This is a block filter

Column/Filter Name Baseline Baseline Measure 1 Sigma Total Operator Greater Than Or Equal To Greater Than Greater Than Or Equal To Value 0 0 4 Universe Object / Filter [Baseline] Measures/CiPM Measures/Baseline Measure [1 Sigma Total] Comments This is a Pre-set Filter and This is a block filter This is a Pre-set Filter and This is a block filter This is a Pre-set Filter and This is a block filter
I2.3.4 Filter Conditions 9 Consecutive Below Baseline

Column/Filter Name Baseline Baseline Measure Baseline Total (9 Below) Operator Greater Than Or Equal To Greater Than Greater Than Or Equal To Value 0 0 9 Universe Object / Filter This is a block filter Measures/CiPM Measures/Baseline Measure [Baseline Total (9 Below)] Comments This is a Pre-set Filter This is a Pre-set Filter This is a Pre-set Filter
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
119 of 155

Alerter Name 3 Sigma 2 Sigma 1 Sigma Any Sigma Violation Below Baseline 1 Sigma Total 2 Sigma Total 3 Sigma Total Baseline Total Purpose if CiPM > 3 Sigma then display the contents of the cell in Red if CiPM > 2 Sigma then display the contents of the cell in Red if CiPM > 1 Sigma then display the contents of the cell in Red if CiPM > 3 Sigma then display the contents of the cell in Black OR if CiPM > 2 Sigma then display the contents of the cell in Black OR if CiPM > 1 Sigma then display the contents of the cell in Black if CiPM < Baseline then display the contents of the cell in Green if I Sigma Total >= 4 then display the contents of the cell in Red if 2 Sigma Total >= 2 then display the contents of the cell in Red if 3 Sigma Total >= 1 then display the contents of the cell in Red if Baseline Total (9 Below) >=9 then display the contents of the cell in Green Applies To Column 3 Sigma 2 Sigma 1 Sigma CiPM Baseline 1 Sig 2 Sig 3 Sig BL
For Review




Requirement Print View Description Too many columns to fit to one page (Depending upon the date values selected in the prompt). Report is formatted to split across pages horizontally in landscape mode.
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
120 of 155
I2.9 Query Design


Variable Baseline Rate Violation Flag CiPM End CiPM Start Issue Concatenated 0 Sigma 1 Sigma 1 Sigma Total 1 Sigma Violation 2 Sigma 2 Sigma Total 2 Sigma Violation 3 Sigma 3 Sigma Total 3 Sigma Violation Baseline Baseline Rate Total Baseline Rate Violation Baseline Total (9 Below) Below Baseline CiPM Distribution Issue Count Max Baseline Period 1 Period 1 Month Purpose If [Baseline Rate Violation] = 1Then "Violation" Else "" UserResponse("Enter Ending Analysis Month:") UserResponse("Enter Starting Analysis Month:") [Product Reported Report Name] + " - " + [Issue Display Item Type] + " - " + [Cause Code] If ([Distribution Quantity] = 0) Then 0 Else ([Baseline Measure] / [Distribution Quantity]) (Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000 Sum([1 Sigma Violation]) Where ([Complaint Initiated Month] Between ([Period 5]; [Period 1])) If [CiPM] > [1 Sigma] Then 1 Else 0 (2*Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000 Sum([2 Sigma Violation]) Where ([Complaint Initiated Month] Between ([Period 3]; [Period 1])) ForEach ([Product Reported Report Name]; [Issue Item Type]; [Cause Code]) ForAll ([Complaint Initiated Month]) If [CiPM] > [2 Sigma] Then 1 Else 0 (3*Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000 Sum([3 Sigma Violation]) Where ([Complaint Initiated Month] = [Period 1]) If [CiPM] > [3 Sigma] Then 1 Else 0 [Baseline Measure] * 1000000 [Baseline Rate Violation] Where ([Complaint Initiated Month] = [Period 1]) If [CiPM] > Max([Lot Check Baseline Rt]) Then 1 Else 0 Sum([Below Baseline]) Where ([Complaint Initiated Month] Between ([Period 9]; [Period 1])) If [CiPM] < [Baseline Measure] * 1000000 Then 1 Else 0 [Issue Quantity Included] / [Distribution Quantity] * 1000000 NoFilter([Production Volume Measure]; All) If IsNull([Issue Count Measure]) Then 0 Else [Issue Count Measure] Max([Baseline Rate]) Max([Distribution Quantity Month]) In Block ToNumber(Substr([Period 1]; 6; 2))
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
121 of 155
Variable Period 1 Year Period 2 Period 3 Period 4 Period 5 Period 6 Period 7 Period 8 Period 9
Purpose ToNumber(Substr([Period 1]; 1; 4)) If [Period 1 Month] > 2 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 1; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 11; "0#") If [Period 1 Month] > 2 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 2; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 10; "0#") If [Period 1 Month] > 4 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 3; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 9; "0#") If [Period 1 Month] > 4 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 4; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 8; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 5; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 7; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 6; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 6; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 7; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 5; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 8; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 4; "0#")
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
122 of 155
I3 Summary Report Tab # 3 Risk Baseline Rate Analysis I3.1 Report Fields Header:
Analysis Month Start Month [Period 1] Min([Compla int Initiated Month]) End Month Formatting Legend [Period 1] Number of Months Analyzed Red Bold = Above Baseline Rate (Max([Distribution Quantity Running Month]) - Min([Distribution Quantity Running Month])) + " Months"
Table:
For Review
Yes Dimensions/Issues/ Cause Code If [Max Baseline] = 500 Then "Minor" ElseIf [Max Baseline] = 100 Then "Major B" ElseIf [Max Baseline] = 50 Then "Major A" ElseIf [Max Baseline] = 5 Then "Critical" Else "N/A" [Lot Check Baseline Rt]
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
123 of 155
CiPM Month Column/Data Desc Yes
Issues Column/Data
CiPM Column/Data
Baseline Rate Column/Data
Column/Data
Totals BL Rate Column/Data
Yes Dimensions/CiPM Dimensions/CiPM Dates/CiPM Month NoFilter([Distributi on Quantity]; All)
Hyperlink [Issue Quantity Included] [CiPM] [Baseline Rate Violation] [Baseline Rate Violation Flag] [Baseline Rate Total]
For Review
I3.2 Prompts
Description Operator Display Text Enter Starting Analysis Month Enter Ending Analysis Month Required/ Optional Optional Required Single/Multi Single Single Type Date Date Default Values Applies To Dimensions/CiPM Dimensions/CiPM Dates/CiPM Month Dimensions/CiPM Dimensions/CiPM Dates/CiPM Month
CiPM Month
Between

Column/Filter Name Baseline Measure Baseline Operator Greater Than Greater Than Or Equal To Value 0 0 Universe Object / Filter Measures/CiPM Measures/Baseline Measure [Baseline] Comments This is a Pre-set Filter This is a Pre-set Filter

Alerter Name Baseline Rate Purpose if CiPM > Max Baseline then display the contents of the cell in Red Applies To Column CiPM, Baseline Rate
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
124 of 155



For Review

I3.9 Query Design


Variable Baseline Rate Violation Flag CiPM End CiPM Start Issue Concatenated 0 Sigma 1 Sigma Purpose If [Baseline Rate Violation] = 1Then "Violation" Else "" UserResponse("Enter Ending Analysis Month:") UserResponse("Enter Starting Analysis Month:") [Product Reported Report Name] + " - " + [Issue Display Item Type] + " - " + [Cause Code] If ([Distribution Quantity] = 0) Then 0 Else ([Baseline Measure] / [Distribution Quantity]) (Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
125 of 155
Variable 1 Sigma Total 1 Sigma Violation 2 Sigma 2 Sigma Total 2 Sigma Violation 3 Sigma 3 Sigma Total 3 Sigma Violation Baseline Baseline Rate Total Baseline Rate Violation Baseline Total (9 Below) Below Baseline CiPM Distribution Issue Count Max Baseline Period 1 Period 1 Month Period 1 Year Period 2 Period 3 Period 4 Period 5 Period 6 Period 7 Period 8 Period 9
Purpose Sum([1 Sigma Violation]) Where ([Complaint Initiated Month] Between ([Period 5]; [Period 1])) If [CiPM] > [1 Sigma] Then 1 Else 0 (2*Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000 Sum([2 Sigma Violation]) Where ([Complaint Initiated Month] Between ([Period 3]; [Period 1])) ForEach ([Product Reported Report Name]; [Issue Item Type]; [Cause Code]) ForAll ([Complaint Initiated Month]) If [CiPM] > [2 Sigma] Then 1 Else 0 (3*Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000 Sum([3 Sigma Violation]) Where ([Complaint Initiated Month] = [Period 1]) If [CiPM] > [3 Sigma] Then 1 Else 0 [Baseline Measure] * 1000000 [Baseline Rate Violation] Where ([Complaint Initiated Month] = [Period 1]) If [CiPM] > Max([Lot Check Baseline Rt]) Then 1 Else 0 Sum([Below Baseline]) Where ([Complaint Initiated Month] Between ([Period 9]; [Period 1])) If [CiPM] < [Baseline Measure] * 1000000 Then 1 Else 0 [Issue Quantity Included] / [Distribution Quantity] * 1000000 NoFilter([Production Volume Measure]; All) If IsNull([Issue Count Measure]) Then 0 Else [Issue Count Measure] Max([Baseline Rate]) Max([Distribution Quantity Month]) In Block ToNumber(Substr([Period 1]; 6; 2)) ToNumber(Substr([Period 1]; 1; 4)) If [Period 1 Month] > 2 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 1; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 11; "0#") If [Period 1 Month] > 2 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 2; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 10; "0#") If [Period 1 Month] > 4 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 3; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 9; "0#") If [Period 1 Month] > 4 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 4; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 8; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 5; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 7; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 6; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 6; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 7; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 5; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 8; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 4; "0#")
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
126 of 155
I4 Summary Report Tab # 4 Risk Baseline Rate Excursions I4.1 Report Fields Header:
Analysis Month Start Month [Period 1] Min([Complaint Initiated Month]) End Month [Period 1] Number of Months Analyzed "Number of Months Analyzed: " + (MonthsBetween(Min([CiPM Date]);Max([CiPM Date]))+1) + " Months"
Table:
Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Product Row Issue Item Type Row Cause Code Row Risk Row Baseline Rate Row Ascending Yes CiPM Month Column/Data Desc Yes (Break on CiPM Month)
For Review
[Product Reported Report Name]
Dimensions/Issues/ Cause Code
[Lot Check Baseline Rt]
Dimensions/CiPM Dimensions/CiPM Dates/CiPM Month
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
127 of 155
Issues Column/Data
CiPM Column/Data
Hyperlink NoFilter([Distribution Quantity]; All) [Issue Quantity Included] [CiPM]
For Review
I4.2 Prompts
Description Operator Display Text Enter Starting Analysis Month Enter Ending Analysis Month Required/ Optional Optional Required Single/Multi Single Single Type Date Date Default Values Applies To Dimensions/CiPM Dimensions/CiPM Dates/CiPM Month Dimensions/CiPM Dimensions/CiPM Dates/CiPM Month
CiPM Month
Between

Column/Filter Name Baseline Rate Total Baseline Rate Total Operator Greater Than Or Equal To Greater Than Value 1 0 Universe Object / Filter [Baseline Rate Total] [Baseline Rate Total] Comments This is a Pre-set Filter and This is a block filter This is a Pre-set Filter and This is a block filter
I4.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report.
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
128 of 155



For Review

I4.9 Query Design


Variable Baseline Rate Violation Flag CiPM End CiPM Start Issue Concatenated Purpose If [Baseline Rate Violation] = 1Then "Violation" Else "" UserResponse("Enter Ending Analysis Month:") UserResponse("Enter Starting Analysis Month:") [Product Reported Report Name] + " - " + [Issue Display Item Type] + " - " + [Cause Code]
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
129 of 155
Variable 0 Sigma 1 Sigma 1 Sigma Total 1 Sigma Violation 2 Sigma 2 Sigma Total 2 Sigma Violation 3 Sigma 3 Sigma Total 3 Sigma Violation Baseline Baseline Rate Total Baseline Rate Violation Baseline Total (9 Below) Below Baseline CiPM Distribution Issue Count Max Baseline Period 1 Period 1 Month Period 1 Year Period 2 Period 3 Period 4 Period 5 Period 6 Period 7 Period 8 Period 9
Purpose If ([Distribution Quantity] = 0) Then 0 Else ([Baseline Measure] / [Distribution Quantity]) (Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000 Sum([1 Sigma Violation]) Where ([Complaint Initiated Month] Between ([Period 5]; [Period 1])) If [CiPM] > [1 Sigma] Then 1 Else 0 (2*Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000 Sum([2 Sigma Violation]) Where ([Complaint Initiated Month] Between ([Period 3]; [Period 1])) ForEach ([Product Reported Report Name]; [Issue Item Type]; [Cause Code]) ForAll ([Complaint Initiated Month]) If [CiPM] > [2 Sigma] Then 1 Else 0 (3*Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000 Sum([3 Sigma Violation]) Where ([Complaint Initiated Month] = [Period 1]) If [CiPM] > [3 Sigma] Then 1 Else 0 [Baseline Measure] * 1000000 [Baseline Rate Violation] Where ([Complaint Initiated Month] = [Period 1]) If [CiPM] > Max([Lot Check Baseline Rt]) Then 1 Else 0 Sum([Below Baseline]) Where ([Complaint Initiated Month] Between ([Period 9]; [Period 1])) If [CiPM] < [Baseline Measure] * 1000000 Then 1 Else 0 [Issue Quantity Included] / [Distribution Quantity] * 1000000 NoFilter([Production Volume Measure]; All) If IsNull([Issue Count Measure]) Then 0 Else [Issue Count Measure] Max([Baseline Rate]) Max([Distribution Quantity Month]) In Block ToNumber(Substr([Period 1]; 6; 2)) ToNumber(Substr([Period 1]; 1; 4)) If [Period 1 Month] > 2 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 1; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 11; "0#") If [Period 1 Month] > 2 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 2; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 10; "0#") If [Period 1 Month] > 4 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 3; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 9; "0#") If [Period 1 Month] > 4 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 4; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 8; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 5; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 7; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 6; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 6; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 7; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 5; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 8; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 4; "0#")
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
130 of 155
I5 Summary Report Tab # 5 Trending Charts I5.1 Report Fields

CiPM Month Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule X-Axis Asc CiPM Y-Axis/Data Plotted Baseline Y-Axis/Data Plotted 1 Sigma Y-Axis/Data Plotted 2 Sigma Y-Axis/Data Plotted 3 Sigma Y-Axis/Data Plotted Issue Concantenated Section Heading Yes
For Review
Dimensions/CiPM Dimensions/CiPM Dates/CiPM Month
[CiPM]
[Baseline]
[1 Sigma]
[2 Sigma]
[3 Sigma]
Right ([Issue Concantenated];0)
I5.2 Prompts
Descripti on CiPM Month Operator Display Text Enter Starting Analysis Month Enter Ending Analysis Month Required/ Optional Optional Required Single/Multi Single Single Type Date Date Default Values Applies To Dimensions/CiPM Dimensions/CiPM Dates/CiPM Month Dimensions/CiPM Dimensions/CiPM Dates/CiPM Month
Between

Column/Filter Name Baseline Baseline Measure Operator Greater Than Or Equal To Greater Than Value Universe Object / Filter [Baseline] Measures/CiPM Measure Comments This is a Pre-set Filter This is a Pre-set Filter
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
131 of 155
I5.4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report. I5.5 Drill Up / Drill Down and Links Not applicable No drill ups / drill downs or links specified for this report. I5.6 Security Requirements
For Review


I5.9 Query Design

Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
132 of 155

Variable Baseline Rate Violation Flag CiPM End CiPM Start Issue Concatenated 0 Sigma 1 Sigma 1 Sigma Total 1 Sigma Violation 2 Sigma 2 Sigma Total 2 Sigma Violation 3 Sigma 3 Sigma Total 3 Sigma Violation Baseline Baseline Rate Total Baseline Rate Violation Baseline Total (9 Below) Below Baseline CiPM Distribution Issue Count Max Baseline Period 1 Period 1 Month Period 1 Year Period 2 Purpose If [Baseline Rate Violation] = 1Then "Violation" Else "" UserResponse("Enter Ending Analysis Month:") UserResponse("Enter Starting Analysis Month:") [Product Reported Report Name] + " - " + [Issue Display Item Type] + " - " + [Cause Code] ([Baseline Measure]) ForEach ([Product Reported Report Name]) / ([Distribution Quantity]) ForEach([Product Reported Report Name]) (Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000 Sum([1 Sigma Violation]) Where ([CiPM Month] Between ([Period 5]; [Period 1])) ForEach([Product Reported Report Name]; [Issue Display Item Type]; [Cause Code]) ForAll ([CiPM Month]) If [CiPM] > [1 Sigma] Then 1 Else 0 (2*Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000 Sum([2 Sigma Violation]) Where ([CiPM Month] Between ([Period 3]; [Period 1])) ForEach([Product Reported Report Name]; [Issue Display Item Type]; [Cause Code]; [Baseline Rate]) ForAll ([CiPM Month]) If [CiPM] > [2 Sigma] Then 1 Else 0 (3*Sqrt ([0 Sigma]) + [Baseline Measure]) * 1000000 Sum([3 Sigma Violation]) Where ([CiPM Month] = ([Period 1])) ForEach([Product Reported Report Name]; [Issue Display Item Type]; [Cause Code]; [Baseline Rate]) ForAll ([CiPM Month]) If [CiPM] > [3 Sigma] Then 1 Else 0 [Baseline Measure] * 1000000 [Baseline Rate Violation] Where ([CiPM Month] = [Period 1]) If [Issue Count Measure] / [Distribution] * 1000000 > Max([Baseline Rate]) Then 1 Else 0 Sum([Below Baseline]) ForAll([CiPM Month]) If [Issue Count] / [Distribution] * 1000000 < NoFilter(Max([Baseline Measure]) * 1000000; All) Then 1 Else 0 [Issue Quantity Included] / ([Distribution Quantity]) ForEach([Product Reported Report Name]) * 1000000 NoFilter([Production Volume Measure]; All) If IsNull([Issue Count Measure]) Then 0 Else [Issue Count Measure] Max([Baseline Rate]) Max([CiPM Month]) In Block ToNumber(Substr([Period 1]; 6; 2)) ToNumber(Substr([Period 1]; 1; 4)) If [Period 1 Month] > 2 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 1; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 11; "0#")
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
133 of 155
Period 3 Period 4 Period 5 Period 6 Period 7 Period 8 Period 9
If [Period 1 Month] > 2 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 2; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 10; "0#")"####") + "-" + FormatNumber([Period 1 Month] + 10; "0#") If [Period 1 Month] > 4 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 3; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 9; "0#") If [Period 1 Month] > 4 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 4; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 8; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 5; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 7; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 6; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 6; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 7; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 5; "0#") If [Period 1 Month] > 8 Then FormatNumber([Period 1 Year]; "####") + "-" + FormatNumber([Period 1 Month] - 8; "0#") Else FormatNumber([Period 1 Year] -1; "####") + "-" + FormatNumber([Period 1 Month] + 4; "0#")
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
134 of 155
J. APPENDIX J - Complaint Issues With Failure Identified Report Report Specification

J1 Report Fields
Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Complaint Type Column Record Type Column Complaint No Column Product Name Column Delivery System Column Issue Item Type Column
hyperlink Yes Dimensions/Complai nts/ComplaintsType Yes Dimensions/Complai nts/Record Type Dimensions/Complai nts/Complaint Number Yes Dimensions/Product/ Product Reported Product Name Dimenstions/Product /Delivery System Dimensions/Issue/Is sue Item Type
For Review
Complaint Initiated Date Column
Issue No Column
Complaint Status Column
Pack Lot No Column
Event Code Column
Cause Code Column
hyperlink Yes Dimensions/Complai nts/Complaint Initiated Date/Complaint Inititated Date Dimenstions/Isuue/Is sue Number Dimensions/Complai nts/Complaint Status
hyperlink ([BTRS Link] Yes Dimensions/Lot/Pac k Lot No Dimensions/Issues/E vent Code Yes Dimensions/Issues/ Cause Code
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
135 of 155
Risk Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule Column
Return Consistent Flag Column
Return Flag Column
Returned Date Column
Complaint Owner Column
Dimensions/Issues/ri sk
Dimensions/ Issues/ Issue Return Consistent Flag
[vReturnFlag]
Dimensions / Complaints / Complaint Return Received Date Closure Code Column
Dimensions / Complaints / Complaint Owner Name
Dimensions / Complaints / Investigation Level
For Review
CMIS Investigation Reference Number Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class/Object or Variable Derived Rule
Failure Column
Failure Identified Date Column Ascending
Yes Dimensions / Issues / CMIS Investigation Reference Number Dimensions / Issue / Failure Code Dimensions/Issues/I ssue Failure Identified Date
Yes Dimensions / Issues / Closure Code
J2 Prompts
Prompt order 1 2 Description Issue Failure Identified Date Issue Failure Identified Date Display Text Enter Issue Failure Identified Date(Start): Enter Issue Failure Identified Date(End): Operator Between Between Required/ Optional Required Required Single/ Multi Single Single Type Date Date Default Values 1/1/2009 1/1/2009
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
136 of 155
J3 Filter Conditions
Column/Filter Name Complaint Type Failure Code Closure Code Operator Not Equal to NotInList NotInList Value Clinical-Type 2' ?;Void;N/A Void Universe Object / Filter Dimensions / Complaint/Complaint Type Dimensions/ Issues / Failure Code Dimensions / Issues / Closure Code
J4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report. J5 Drill Up / Drill Down and Links
Drill/Link Name Link To BTRS Drill Path / Link To Pack Lot No. linked to Cognos BTRS Report Prompt Page Description "<a href=\"http://bi.amgen.com/cognos8/cgi-bin/cognos.cgi?b_action=xts.run&m=portal%2Freportviewer.xts&ui.action=run&ui.object=%2Fcontent%2Fpackage%5B%40name%3D%27BTRS+%28Batch+Trace+Rep orting+System%29%27%5D%2Freport%5B%40name%3D%27Batch+Trace+Report%27%5D&cv.ccurl=1&p_Temp BatchNumbers="+URLEncode(""+[Pack Lot No])+"&p_BatchTypes=A&p_TraceDirection=B&p_ReportLevel=M&p_MaterialTypesIncludeExclude=N&p_MfgStag esIncludeExclude=N&p_TempMaterialTypes=%3CNo+Filter%3E&p_TempMfgStages=%3CNo+Filter%3E&p_Inclu deACMSourceBatches=N&p_IncludeSections=SummaryPage\" title=\"\" target=\"_blank\" nav=\"web\">"+[Pack Lot No]+"</a>" "<a href=\"../../opendoc/openDocument.jsp?iDocID=AaOhBfZot6tMv_chGmnRKG0&sIDType=CUID&sType=wid&sRefr esh=Y&lsSEnter%20Complaint%20Number%3A="+URLEncode(""+[Complaint Number])+"&sWindow=New\" title=\"\" target=\"_self\" nav=\"doc\">"+[Complaint Number]+"</a>" "<a href=\"../../opendoc/openDocument.jsp?iDocID=AewTF9R8P0pIsau6mvhuFj4&sIDType=CUID&sType=wid&lsSEnt er%20Issue%20Number%3A="+URLEncode(""+[Issue Number])+"&sWindow=New\" title=\"\" target=\"_self\" nav=\"doc\">"+[Issue Number]+"</a>"
For Review
Complaint No.
Complaint Drill Report
Issue No.
Issues Drill Report
J6 Security Requirements
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
137 of 155
J7 Performance Requirements
J8 Print Requirements
Requirement Print View Description Landscape - columns span across 2 horizontal pages
J9 Query Design
For Review
J10 Report Variables Design

Variable vreturnFlag BTRS Link Purpose If IsNull([Complaint Return Received Date]) Then "N" Else "Y" "<a href=\"http://bi.amgen.com/cognos8/cgi-bin/cognos.cgi?b_action=xts.run&m=portal%2Freportviewer.xts&ui.action=run&ui.object=%2Fcontent%2Fpackage%5B%40name%3D%27BTRS+%28Batch+Trace+Reporting+System%29%27 %5D%2Freport%5B%40name%3D%27Batch+Trace+Report%27%5D&cv.ccurl=1&p_TempBatchNumbers="+URLEncode(""+[Pack Lot No])+"&p_BatchTypes=A&p_TraceDirection=B&p_ReportLevel=M&p_MaterialTypesIncludeExclude=N&p_MfgStagesIncludeExclude=N&p_ TempMaterialTypes=%3CNo+Filter%3E&p_TempMfgStages=%3CNo+Filter%3E&p_IncludeACMSourceBatches=N&p_IncludeSections=Su mmaryPage\" title=\"\" target=\"_blank\" nav=\"web\">"+[Pack Lot No]+"</a>" [Product Reported Report Name] - Created so that the interactive report filter has the right name If [Closure Code]="?" Then "" Else [Closure Code]
Product Name vClosureCode
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
138 of 155
K. APPENDIX K - Drill Table Complaint Report Specification

K1 Report Fields
Record Type Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class / Object or Variable Derived Rule Column Complaint Type Column IO Site Column Complaint No. Column Complaint Initiated Date Column Complaint Owner Column
For Review
Dimensions / Complaints / Complaint Investigating Site / Dept / IO Site Initiator Site Column
Dimensions / Complaints / Complaint Number
Dimensions / Complaints / Complaint Initiated Date / Complaint Initiated Date Complaint Closed Date Column
Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class / Object or Variable Derived Rule
Complainant Country Column
Initiator Name Column
Max Investigation Level Column
Dimensions / Complaints / Complainant / Complainant Country
Dimensions / Complaints / Complaint Initiator / Complaint Initiator Name
Dimensions / Complaints / Complaint Initiator / Complaint Initiator Site
Dimensions / Complaints / Complaint Closed Date / Complaint Closed Date
Report Variable or Calculation
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
139 of 155
Event Summary Column
Product Column
Pack Lot Number Column
Delivery System Column
Aer Assoc Flag Column
Aer No Column
Dimensions / Complaints / Complaint Event Summary
Dimensions / Complaints / Lot / Pack Lot No
Dimensions / Complaints / Product Reported / Product Reported Delivery System Code
Dimensions / Complaints / Aer Assoc Flag
Dimensions / Complaints / Aer No
For Review
Dose Administered Flag Column
Response Required Flag Column
Dimensions / Complaints / Complaint Dose Administered Flag
Dimensions / Complaints / Complaint Written Response Type
K2 Prompts
Prompt order 1 2 Description Complaint Number Complaint Initiated Month Display Text Enter Complaint Number: Enter Complaint Initiated Month: Operator Equal to Equal to Required/ Optional Optional Optional Single/Multi Single Single Type String String Default Values
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
140 of 155
Prompt order 3
Description Complaint Open - Overdue Status Complaint Initiated Quarter Complaint Overdue-Ontime Status Product Reported Report Name Complaint Initiated Year Complaint Open/Closed Status Region Investigation Level Record Type Complaint Type Complaint Type Complaint OverDueOpenClosedStat us Complaint Closed Year Complaint Due Year (45 Days) IO Site Delivery Sytem Product Name IO Dept
Display Text Enter Value(s) for Complaint Open - Overdue Status: Enter Complaint Initiated Quarter: Enter Complaint Overdue-Ontime Status: Enter Product Reported Report Name: Enter Complaint Initiated Year: Enter Complaint Open/Closed Status: Enter Region: Enter Complaint Investigation Level: Enter Complaint Record Type: Enter Complaint Type: Enter value(s) for Complaint OverDueOpenClosedStat us: Enter Complaint Closed Year Enter Complaint Due Year: Enter IO Site: Enter Delivery System: Enter Product Name: Enter IO Dept:
Operator In List
Required/ Optional Optional
Single/Multi Multi
Type String
Default Values
4 5 6 7 8 9 10 11 12 13 14
Equal to Equal to Equal to Equal to Equal to Equal to Equal to Equal to Equal to Not Equal to In List
Optional Optional Optional Optional Optional Optional Optional Optional Optional Optional
Single Single Single Single Single Single Single Single Single Multi
Date String String Date String String String String String Clinical - Type 2 String
For Review
15 16 17 18 19 20
Equal to Equal to Equal to Equal to Equal to Equal to
Optional Optional Optional Optional Optional Optional
Single Single Single Single Single Single
String String String String String String
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
141 of 155
Prompt order 21 22 23 24 25 26
Description Complaint Due Quarter (45 Days) Complaint Due Month (45 Days) Complaint Due Year (30 Days) Complaint Due Quarter (30 Days) Complaint Due Month (30 Days) Complaint Overdue-Ontime Status(45 Days) Complaint Overdue-Ontim Status(30 Days) Complaint Status Complaint Overdue-Ontime Status(45/90) Complainant Country Complaint Closed Quarter Complaint Closed Month Complaint Closed Date Complaint Owner Name
Display Text Enter Complaint Due Quarter (45 Days): Enter Complaint Due Month (45 Days): Enter Complaint Due Year (30 Days): Enter Complaint Due Quarter (30 Days): Enter Complaint Due Month (30 Days): Enter Complaint OverDueOnTime Status(45 Days): Enter Complaint OverDueOnTime Status(30 days): Enter Value(s) for Complaint Status: Enter Complaint Overdue-Ontime Status(45/90): Enter Complainant Country: Enter Complaint Closed Quarter: Enter Complaint Closed Month: Enter Complaint Closed Date: Enter Complaint Owner Name:
Operator Equal to Equal to Equal to Equal to Equal to Equal to
Required/ Optional Optional Optional Optional Optional Optional Optional
Single/Multi Single Single Single Single Single Single
Type String String String String String String
Default Values
For Review
27
Equal to
Optional
Single
String
28 29 30 31 32 33 34
In List Equal to Equal to Equal to Equal to Equal to Equal to
Optional Optional Optional Optional Optional Optional Optional
Multi Single Single Single Single Single Single
String String String String String Date String
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
142 of 155
Prompt order 35
Description Complaint Cycle Time - Initiated to Closed Complaint Initiated Date Complaint Due Date (45 Days) Record Type Target Days To Close Complaint Owner Staff Key
Display Text Enter Complaint Cycle Time Initiated to Closed: Enter Complaint Initiated Date: Enter Complaint Due Date (45 Days): Enter Record Type Target Days To Close: Enter Complaint Owner Staff Key:
Operator Equal to
Required/ Optional Optional
Single/Multi Single
Type Number
Default Values
36 37 38 39
Equal to Equal to Equal to Equal to
Optional Optional Optional Optional
Single Single Single Single
Date Date Number String
For Review
K3 Filter Conditions
Column/Filter Name Complaint Type Operator Not Equal To Value Clinical - Type 2 Universe Object / Filter Dimensions/Complaints/ Complaint Type
K4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report. K5 Drill Up / Drill Down and Links Not applicable No drill up / drill down or links specified for this report. K6 Security Requirements
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
143 of 155
K7 Performance Requirements
K8 Print Requirements
Requirement Print View Description Too many columns to fit to one page. Report is formatted to split across 2 pages horizontally in landscape mode.
K9 Query Design
Query Complaints Drill Query Purpose Main query
For Review
K10 Report Variables Design

Variable Max Investigation Level Purpose Calculates max investigation level for complaint
K11 Prompt Summary Page

2nd Tab Name Report Prompt Summary Definition PromptSummary()
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
144 of 155
L. APPENDIX L - Drill Table Issue Report Specification

L1 Report Fields
Record Type Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class / Object or Variable Derived Rule Column Complaint Type Column IO Site Column Complaint Initiated Date Column Complaint Owner Column Complaint Status Column
For Review
Dimensions / Complaints / Complaint Investigating Site / Dept / IO Site Pack Lot Number Column
Dimensions / Complaints / Complaint Initiated Date / Complaint Initiated Date Manufactured By Column
Product Column
Complaint No Column
Dimensions / Complaints / Complaint Investigating Level
Dimensions / Issues / Lot Item / Lot Item Manufactured By
Dimensions / Complaints / Product / Delivery System
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
145 of 155
Issue Number Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class / Object or Variable Derived Rule Column
Amgen Lot Number Column
Vendor Lot Number Column
Issue Status Column
Complaint Owner Column
Previous Investigation Flag Column
For Review
Dimensions / Issues / Issue Number
Dimensions/Issues/L ot Item/Amgen Lot Number
Dimensions/Issues/L ot Item/Vendor Lot Number
Dimensions / Issues / Issue Status
Dimensions / Complaints / Complaint Owner Name Risk Column
Dimensions / Issues / Issue Prev Investigation Flag
Investigation Ref No. Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class / Object or Variable Derived Rule Column
Item Type Column
Event Code Column
Cause Code Column
Dimensions / Issues / CMIS Investigation Reference Number
Dimensions / Issues / Issue Item Type
Dimensions / Issues / Event Code
Dimensions / Issues / Cause Code
Dimensions / Issues / Risk
Dimensions / Issues / Issue Return Consistent Flag
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
146 of 155
Failure Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class / Object or Variable Derived Rule Column
Failure Identified Date Column
Closure Code Column
Number Of Issues Column (Hidden)
Event Category Column(Hidden)
Issue Summary Column(Hidden)
Dimensions / Issues / Failure Code
Dimensions / Issues / Issue Failure Identified Date
Dimensions / Issues / Closure Code
Measures / issue Measures / Number Of Issues
Dimensions / Issues / Event Category Code
Dimensions / Issues / Issue Summary
For Review
CAPA Req Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class / Object or Variable Derived Rule Column (Hidden)
CAPA No Column (Hidden)
Units Reported Column (Hidden)
Complainant Country Column (Hidden)
Initiator Name Column (Hidden)
Initiator Site Column (Hidden)
Dimensions / Issues / CAPA Required Flag
Dimensions / Issues / CAPA Number
Dimensions / Issues / Issue Units Reported
Dimensions/Compla ints/Complainant/Co mplainant Country
Dimensions / Complaints / Complaint Initiator / Complaint Initiator Name
Dimensions / Complaints / Complaint Initiator / Complaint Initiator Site
L2 Prompts
Prompt order 1 Description Complaint Status Display Text Operator Not In List Required/ Optional Single/Multi Type Default Values Voided
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
147 of 155
Prompt order 2
Description Complaint Type
Display Text
Operator Not In List
Required/ Optional
Single/Multi
Type
Default Values Commercial Type 1;Commercial Type 2;Clinical Type 2
3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
Issue Number Cause code Product Name Issue Closed Year Issue Item Type Issue Closed Quarter Complaint Initiated Month Complaint Initiated Quarter Complaint Initiated Year Issue Closed Month Product Reported Report Name Complaint Type IO Site Record Type Region Issue Included Flag Delivery System CiPM Year
Enter Issue Number: Enter Cause Code: Enter Product Name: Enter Issue Closed Year: Enter Issue Item Type: Enter Issue Closed Quarter: Enter Complaint Initiated Month: Enter Complaint Initiated Quarter: Enter Complaint Initiated Year: Enter Issue Closed Month: Enter Product Reported Report Name: Enter Complaint Type: Enter IO Site: Enter Record Type: Enter Region: Enter Issue Included Flag Enter Delivery System: Enter value(s) for CiPM Year:
Equal To Equal To Equal To Equal To Equal To Equal To Equal To Equal To Equal To Equal To Equal To Equal To Equal To Equal To Equal To Equal To Equal To In list
Optional Optional Optional Optional Optional Optional Optional Optional Optional Optional Optional Optional Optional Optional Optional Optional Optional Optional
Single Single Single Single Single Single Single Single Single Single Single Single Single Single Single Single Single Multi
String String String String String String String String String String String String String String String 1 or 0 String String
For Review
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
148 of 155
Prompt order 21 22 23
Description CiPM Quarter CiPM Month Production Volume Measure Complaint Initiated Year Complaint Initiated Quarter Complaint Initiated Month
Display Text Enter value(s) for CiPM Quarter: Enter value(s) for CiPM Month: Enter value(s) for Production Volume Measure: Enter Ranking value for Year: Enter Ranking value for Quarter: Enter Ranking value for Month:
Operator In list In list In list
Required/ Optional Optional Optional Optional
Single/Multi Multi Multi Multi
Type String String Number
Default Values
24 25 26
Equal To Equal To Equal To
Optional Optional Optional
Single Single Single
String String String
OR
For Review
L3 Filter Conditions Not applicable No filters specified for this report. L4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report. L5 Drill Up / Drill Down and Links
Drill/Link Name Complaint No Drill Path / Link To Description <a href=\"../../opendoc/openDocument.jsp?iDocID=ASFH8HAFr8ZBhdxnlqgnTz8&sIDType=CUID&sType=wid&lsSEnter %20Complaint%20Number%3A="+URLEncode(""+[Complaint Number])+"&sWindow=New\" title=\"\" target=\"_self\" nav=\"doc\">"+[Complaint Number]+"</a>"
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
149 of 155
L6 Security Requirements
L7 Performance Requirements
L8 Print Requirements
Requirement Print View Description Too many columns to fit on one page. Split into multiple pages (3) in landscape mode for printing
For Review
L9 Query Design
Query Issues Drill Query Purpose main query
L10 Report Variables Design Not applicable No report variables specified for this report. L11 Prompt Summary Page
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
150 of 155
M.
APPENDIX M - Drill Table Assessment Report Specification
M1 Report Fields
Record Type Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class / Object or Variable Derived Rule Column Complaint Type Column IO Site Column Complaint No. Column Complaint Initiated Date Column Complaint Owner Column
For Review
Dimensions / Complaints / ComplaintsType
Dimensions / Complaints / Complaint Investigating Site / Dept / IO Site Product Column
Dimensions / Complaints / Complaint Initiated Date / Complaint Initiated Date Manufactured By Column
Pack Lot Number Column
Dimensions / Complaints / Investigation Level
Dimensions / Issues / Lot Item / Lot Item Manufactured By
Dimensions / Complaints / Product / Delivery System
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
151 of 155
Issue No Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class / Object or Variable Derived Rule Column
Issue Created Date Column
Issue Status Column
Previous Investigation Flag Column
Investigation Ref No Column
Item Type Column
Dimensions / Issues / Issue Number
Dimensions / issues / Issue Opened Date / Issue Opened Date
Dimensions / Issues / Issue Status
Dimensions / Issues / Issue Prev Investigation Flag
Dimensions / Issues / CMIS Investigation Reference Number
Dimensions / Issues / Issue Item Type
For Review
Event Code Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class / Object or Variable Derived Rule Column
Cause Code Column
Risk Column
Failure Column
Assessment Type Column
Dimensions / Issues / Event Code
Dimensions / Issues / Cause Code
Dimensions / Issues / Risk
Dimensions / Issues / Issue Return Consistent Flag
Dimensions / Issues / Failure Code
Dimensions / Assessments / Assessment Type
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
152 of 155
Assessment Site Position Section Sort Break Sub Total Format Interactive Report Filters Universe Class / Object or Variable Derived Rule Column
Assessment No. Column
Assessment Created Date
Assessor Name Column
Assessment Received Date Column
Assessed Date Column
Dimensions / Assessments / Assessor / Assessor Site Approved Date
Dimensions / Assessments / Assessment Number
Dimensions / Assessments / Assessment Opened Date Assessment Status Column
Dimensions / Assessments / Assessor / Assessor Name Date Forw To Ext Assessor Column
Dimensions / Assessments / Ext Assessment Received Date Date Ackn by Ext Assessor Column
Dimensions / Assessment / Assessment Signed Date
For Review
Column
Assessment Days Open Column
Dimensions / Assessments / Assessment Owner Approval Date
[AssessmentsDaysO pen]
Dimensions / Assessments / Assessment Status
Dimensions / Assessments / Forward To Ext Assessor Date
Dimensions / Assessments / Ext Assessor Acknowledge Date
M2 Prompts
Prompt order 1 2 Description Assessment Number Assessor Site Display Text Enter Assessment Number: Enter value(s) for Assessor Site: Operator Equal To In List Required/ Optional Optional Optional Single/Multi Single Multi Type String String Default Values
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
153 of 155
Prompt order 3 4 5 6 7 8 9 10 11 12 13
Description Amgen/NonAmgen Site Assessment Due Year Assessment Due Quarter Assessment Due Month Assessor Name Complaint Type IO Site Investigation Level Product Name Record Type Assessment Due Date
Display Text Enter value(s) for Amgen / NonAmgen Site: Enter Assessment Due Year: Enter Assessment Due Quarter: Enter Assessment Due Month: Enter Assessor Name: Enter Complaint Type: Enter IO Site: Enter Investigation Level: Enter Product Name: Enter Record Type: Enter Assessment Due Date(Start): Enter Assessment Due Date(End): Enter Product Reported Report Name: Enter Delivery System: Enter Assessment Type: Enter Issue Status:
Operator In List Equal To Equal To Equal To Equal To Equal To Equal To Equal To Equal To Equal To Between
Required/ Optional Optional Optional Optional Optional Optional Optional Optional Optional Optional Optional Optional
Single/Multi Multi Single Single Single Single Single Single Single Single Single Single
Type String String String String String String String String String String Date
Default Values
For Review
14 15 16 17
Product Reported Report Name Delivery System Assessment Type Issue Status
Equal To Equal To Equal To Not Equal To
Optional Optional Optional Optional
Single Single Single Single
String String String String
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
154 of 155
Prompt order 18 19 20 21
Description Complaint Number Complaint Status Assessment Status Assessment Status Assessment Open Date Assessment Completed Date Assessment Target Days to Close
Display Text Enter Complaint Number: Enter Complaint Status: Enter Assessment Status: Enter Assessment Status that is Not Equal to: Enter Assessment Open Date: Enter Assessment Completed Date: Enter Assessment Target Days To Close:
Operator Equal To Equal To Equal To Not Equal To
Required/ Optional Optional Optional Optional Optional
Single/Multi Single Single Single Single
Type String String String String
Default Values
22 23 24
Equal To Equal To Equal To
Optional Optional Optional
Single Single Single
String String String
For Review
M3 Filter Conditions Not applicable No filters specified for this report. M4 Alerts and Conditional Formatting Not applicable No alerts or conditional formatting specified for this report. M5 Drill Up / Drill Down and Links Not applicable No drill up / drill down or links specified for this report. M6 Security Requirements
Amgen Confidential
DOCUMENT NO.
RS-000885
TITLE
3.4
155 of 155
Security Requirement PCMT Users PCMT Super Users
Description Can view in HTML and Only Export to PDF Can view in HTML and Export to PDF and Excel
M7 Performance Requirements
M8 Print Requirements
Requirement Print View Description Too many columns to fit in one page. Columns get distributed to 4 pages in Landscape mode.
For Review
M9 Query Design
Query Assessments Drill Query Purpose Main Query
M10 Report Variables Design

Variable AssessmentsDaysOpen Purpose DaysBetween([Assessment Opened Date];[Assessment Closed Date])
M11 Prompt Summary Page

Amgen Confidential

PCMT Reports

Hochgeladen von

Dokumentinformationen

Originalbeschreibung:

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

PCMT Reports

Hochgeladen von

Copyright:

Verfügbare Formate

Requirements Specification

STATUS APPROVED DATE

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

RFC Number RFC039328

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Definitions and Abbreviations

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Abbreviation EDW ETL GPSS IO LDAP PC PCMT PQS PSI SI TI

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Data Requirements are divided into three sub-sections:

Transfer Data from the Staging Area to Data Core

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

The following self-service reports shall be developed for PCMT:

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaint Closure Performance Cycle Time

Product Complaint Initiated Rate:

Right First Time Report

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Interim Report Adherence:

Open vs. Overdue Complaints:

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Overall Product Complaint/Issues Rates

Top Product Complaint Cause Codes by Product

Site/Partner Performance in Complaint Assessments Management

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Periodic Product Complaint Excursion Report

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

System-wide Business Rules

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Historical Data Requirements

Data Completeness and Accuracy Requirements

Data Reconciliation Requirements

System Availability Requirements

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Report and Query Performance Requirements

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

Product Complaints Metrics & Trending (PCMT) - Requirements Specification

ID/Number Requirement Text

SOP-014441 PCMT Administration SOP-013934 EDW Administration and Operations

SOP-014441 PCMT Administration

Product Complaints Metrics & Trending (PCMT) - Requirements Specification