INSTALLATION QUALIFICATION PROTOCOL FOR ERP

SYSTEM

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INSTALLATION QUALIFICATION
PROTOCOL
FOR ERP SYSTEM
 INSTALLATION QUALIFICATION PROTOCOL FOR ERP
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APPROVAL PAGE

BY Arizona Automation & Technologies:

Prepare by:

Name Designation Signature Date

Review by:

Name Designation Signature Date

By Windlas Healthcare (P) Ltd.:

Review by:

Name Designation Signature Date

Approved by:

Name Designation Signature Date

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REVISION HISTORY

Version / Revision
Date Revised Reason for Revision
Number
00 First Release
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TABLE OF CONTENTS
1.0 OBJECTIVE ..............................................................................................................................5
2.0 SCOPE ........................................................................................................................................5
3.0 RESPONSIBILITIES ...............................................................................................................5
4.0 TESTING INSTRUCTIONS ....................................................................................................6
5.0 TEST STRATEGY ....................................................................................................................7
5.1 Execution Team...........................................................................................................................7
5.2 Protocol Execution ......................................................................................................................7
5.3 Qualification Completion and Approval .....................................................................................7
6.0 ACCEPTANCE CRITERIA ....................................................................................................8
7.0 TESTS.........................................................................................................................................9
7.1 Verification of Master Documents ............................................................................................10
7.2 Verification of Installed Software .............................................................................................11
8.0 SUMMARY OF TEST RESULTS.........................................................................................12
9.0 DISCREPANCIES HANDLING DURING INSTALLATION QUALIFICATION ........13
10.0 CONCLUSION STATEMENT ..............................................................................................14
11.0 LIST OF ANNEXURE ............................................................................................................16
12.0 ABBREVIATION....................................................................................................................17
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1.0 OBJECTIVE

The objective of the installation qualification is to establish documented evidence that the ERP
software is installed as intended according to the Design specification (DS) at Windlas Healthcare (P)
Ltd.

2.0 SCOPE
This Installation Qualification Protocol is applicable to systems/components installed at Windlas
Healthcare (P) Ltd.

3.0 RESPONSIBILITIES
The validation group comprising of a representative from each of the following departments shall be
responsible for the overall compliance with this Protocol cum report:
• Arizona Automation & Technologies

To verify all manuals, drawings and documentation or any other data necessary for the
preparation and execution of this Protocol cum report.

Preparation of Protocol.

Execution of Protocol.

Report Preparation

Discrepancy reporting

• IT Department

To provide necessary documents required for qualification.

To co-ordinate during verification activities.

To witness of the qualification activity.

Execution of tests.

Report Preparation

Discrepancy reporting.

Verification of tests

• Quality Assurance

Support the validation Agency in the preparation of Qualification Protocol.

Approve Qualification Protocol.

Support the validation agency in the Execution of Qualification Protocol.

Review of documents & Discrepancy closures.

Final report verification and approvals.
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4.0 TESTING INSTRUCTIONS

Following are the instructions for executing this Protocol. Each tester or reviewer executing any portion
of this Protocol must read these instructions prior to execution. You must resolve any questions or
uncertainties you have prior to executing this Protocol. Once these instructions are completely
understood, make an entry in the signature table on the following page.
Performing Tests and Recording Results
Record handwritten entries and test results in blue ball point pen.
For each test, perform the instructions indicated in the procedure section of each test. Provide annexure
as objective evidence to support recordings made while executing the test.
The annexure (s) for a test must be inserted in sequential order (e.g. Annexure 1, Annexure 2, etc.)
immediately behind the test to which it is referenced. A highlighter may be used to emphasize data
contained in an annexure.
Verifying and Reviewing Test Results
After the tester signs the test result, separate persons must verify and review the test for the following:
• An actual result has been recorded
• Any reference annexure are present
• The test signature block was correctly completed by the tester
• If the actual result does not match the expected result, a discrepancy report form has been
initiated.
Resolving Discrepancies
Discrepancies include the following scenarios:
• Actual results for a test do not match expected results
• Non availability of appropriate documentation
• Non availability of required Standard Operating Procedures

Note: A typographical error only requires a “line-through” correction accompanied by the person’s
initials and date (If required, with justification)
Each discrepancy must be identified, the cause must be determined, the impact must be assessed, and a
resolution must be made. Each discrepancy must be enlisted in Discrepancies Handling during
Qualification ANNEXURE and documented in a Discrepancy Report Form.
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5.0 TEST STRATEGY

The satisfactory installation qualification of the ERP software shall be verified by executing the
qualification tests described in protocol. The successfully executed protocol documents verify that the
ERP system produces appropriate results as required and is satisfactorily integrated.

5.1 Execution Team

Mention below the list of personnel with their designation, full and short signatures responsible for
execution and review of Installation Qualification Protocol.

Full Short
Full Name Designation
Signature/Date Signature/Date

5.2 Protocol Execution

The satisfactory installation and integration of the ERP Software shall be verified by executing the
qualification studies described in this protocol. The successfully executed protocol documents that the
ERP Software is installed as required and is satisfactorily integrated.

5.3 Qualification Completion and Approval

• Verify that all tests required by this protocol are completed, reconciled and attached to this
protocol.
• Verify that all amendments and discrepancies are documented, approved and attached to this
protocol.
• If all items in the Installation Qualification Protocol for ERP Software have been reviewed and
found to be acceptable, sign the corresponding block in the Approval form.
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6.0 ACCEPTANCE CRITERIA

The acceptance criteria includes,

• Installation of the system with utility connections as mentioned in Design Specification document.
• Availability of necessary technical documentation.
• Installation of ERP application software at server as per Design Specification document.
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7.0 TESTS

Sr. No. Test Description

7.1 Verification of Master Documents
7.2 Verification of Installed Application Software
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7.1 Verification of Master Documents

Objective : To ensure that system is adequately documented and this

documentation is under appropriate document control.

Tools required : Not Applicable

Procedure : Verify availability of the following documents related to

installation and operation of ERP and verify their revision no.,
date, etc. details.
• Design Specification Document
• Licenses of all installed software
• List of ERP Process System users
• ERP Software Installation Manual
A. Identification of the documents

1. The executor will check whether all the documents are

available or not. For all the documents the documents number,
proper description with name should be available.
2. The effective date of the documents should be verify if
available.
3. Note down the details in Test Table.

B. Check the correctness of the documents

1. The executor will identify the documents and compare that the
documents represent the actual installed system.
2. Authorized person should have signed all the documents.
3. The documents should be upgraded as per the latest system.
4. Note down the details in Test Table.

Acceptance : 1. The documents should display proper information for

criteria installation and operation of ERP System.
2. The documents should have proper document name, number
and signed.
Reference : 1. Annexure – 1
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7.2 Verification of Installed Software

Objective : This test sheet of the IQ is intended to verify installed application

software.
Tools required : Not Applicable

Procedure : 1. Verify the installed application software.

2. Record the details mentioned in Annexure 2.
Acceptance : 1. The Application software configuration should comply as per
criteria Design Specification.

Reference : 1. Annexure – 2
2. Design Qualification (CSV/ERP/DQ-17-00)
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8.0 SUMMARY OF TEST RESULTS

This section summarizes the results of the testing and references any discrepancies that have been
documented during protocol test execution. The following text should be used in this section:

Discrepancy
Test Checked By
Verification Test Pass/Fail Found?
No. / Date
Yes/No
Verification of Master
7.1
Documents
Verification of Installed
7.2
Application Software
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9.0 DISCREPANCIES HANDLING DURING INSTALLATION QUALIFICATION

Record each discrepancy in the table below and attach the completed discrepancy form(s). (Note:
Mark a line through any remaining blank lines in the table, then initial and date)
Minor Discrepancy (Category A)
Sr. Discrepancy Information

Major Discrepancy (Category B)

Sr. Discrepancy Information

Developmental work required/Not required:

(Attach details)
Critical Discrepancy (Category C)
Sr. Discrepancy Information

Developmental work required/Not required:

(Attach details)

Category A (minor): Discrepancy is accepted with deficiency

Category B (major): Provisional or conditional acceptance, discrepancy to be corrected either by
developer within stipulated time period
Category C (critical): Discrepancy to be rectified before proceeding further

Section completed by: ______________________________________

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CONCLUSION STATEMENT

Summary
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Conclusion

Section completed by: ___________________________________________

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10.0 LIST OF ANNEXURE

This section provides summary of Annexure attached with protocol as test evidences.
Reference
Sr. No. Description Of Annexure
Test No.
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11.0 ABBREVIATION

Abbreviation Full form

ERP Enterprise Resource Planning
IQP Installation Qualification Protocol
SOP Standard Operating Procedure
GAMP Good Automated Manufacturing Practices
IT Information Technology
QA Quality Assurance
NA Not Applicable