Local Case Handling Best Practices Unlocked

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Document Information:
Document Author: Westergaard, Gaston {DQMC~Rotkreuz-Tro}
Business Area / Unit: Logistics & All Sites
Confidentiality: Confidential
Document Class: Device Master Record
Document Type: Device Master Record with Review
Document Creator: Westergaard, Gaston {DQMC~Rotkreuz-Tro}
Document Lifecycle Status: Effective
Valid From: 05-Jul-2017 16:30:22 (UTC)
Valid To:
Document Title: Local Case Handling Best Practices
Document Number: 0000000000001200000242322
Document Version: 01
Template: No
Global Group: Global Complaint Management

Global SubGroup: Work Instruction WI
Site: Rotkreuz
Document Description: This Best Practice provides guidelines for the timely, accurate
and complete handling and documentation of inquiries, support
requests, complaints and logistic claims opened at affiliates and
other local organizations
Electronic Signatures:
Signed By: westergg (Gaston Westergaard {DQMC....5780})
Role: Author
Signature Differentiation: Case Monitoring and Resolution
Signed Date: 04-Jul-2017 12:19:48 (UTC)
Signed By: dillonbj (Jennifer Dillon-Beem {DNPC....2846})

Role: Reviewer
Signature Differentiation: Global Customer Support
Signed By: kuhsep (Philipp Kuhse {DEGSSD..6195})

Role: Reviewer
Signature Differentiation: Project Management
Signed By: moltenig (Giorgio Molteni {DEIR....1625})

Role: Reviewer
Signature Differentiation: Regulatory Affairs
Signed By: pinderr (Robert Pinder {DQMC....6019})

Role: Approver
Signature Differentiation: Case Monitoring and Resolution
Title: Local Case Handling Best Practices Document Number: 0000000000001200000242322

Version: 01 Status: Effective Valid from: 05-Jul-2017 16:30:22 (UTC)
Print Date: 28-Jul-2017 14:46:03 (UTC)
Print Comment: Cover Page 1 (2)
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Print Comment: Cover Page 2 (2)
Local Case Handling
Best Practices Handbook
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Confidentiality: Confidential Content Page 1 (36)
Table of Content
Document History
Purpose
Scope
Process Overview
Sections
Case Creation
Documentation on a Case
Working on a Case
Escalation
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Document History
Version Reason for change Effective from
00 First release Date of approval
Purpose
This Best Practice provides guidelines for the timely, accurate and complete handling and
documentation of inquiries, support requests, complaints and logistic claims opened at
affiliates and other local organizations
Scope
All RD Country Organizations (aka Affiliates), RCSC, MCs, and agency / distributor
personnel who may encounter, report, or process cases (complaints/ inquiries/support
requests/Logistic claims) relating to an RD product is encouraged to follow the best practices
described in this handbook.
Process Overview
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Sections
Case creation
How to start a local case by searching for the serial number

o Local case creation should begin by searching for the instrument serial #
provided by the customer within Rexis or Prisma/Clarify. If the instrument
serial # was provided to an IVR (Interactive Voice Response) system, be sure
to verbally confirm the serial # with the customer. This will ensure you create
the local case against the appropriate instrument. You can ensure you have
the correct instrument selected by checking the IB and Account information
associated with your search.
How to create a case without a customer/account number

o In the event that the customer does not have an account # or serial # to search
by, the case should be created using a generic pre-established account #
within Rexis or Prisma/Clarify. Utilize your local policies/procedures to
determine your next steps in logging a call when no account/serial #
provided.
o Specific to Point Of Care, in the event an individual customer (patient)
contacts us and has no customer/account number, the contact is created in
Rexis as an Individual contact. The corresponding account is created
automatically in the background. To create a new individual contact, the user
needs the POC permission set.
How to handle multiple serial numbers, account numbers for a customer

o Because there can be duplicate serial #s across different instrument
lines/families and multiple account numbers for each site, it is imperative
that the customers account number and serial # is verified on every call.
o If only the serial # can be verified, verbally verify the account name and
address that the customer is calling from and ensure it matches the account
associated with the serial #. This will ensure that you do not incorrectly log a
call against the wrong instrument or wrong account number. This is critical
when dispatching field personnel or sending product to troubleshoot an issue.
How to manage a case when initially logged against the incorrect serial
#(core vs module)
o It is imperative that the LCH verify the serial # of the product with the
customer before creating a case as it can be difficult to get this updated after
the fact. In the event that the case is created against the wrong serial # and
the case has not been dispatched or escalated, the LCH can update the serial #
locally.
o In Rexis, if the case has been dispatched to field personnel or escalated to
global, the serial # update can only be performed by specially trained
personnel or Rexis team.
In the event that the dispatch service activity has been accepted by the
FSE and is in a transferred status, the dispatch service activity will
need to be revoked and cancelled before the serial # can be updated by
the Rexis Team.
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o In Prisma/Clarify, the LCH can make the update, but must clearly document
in their case notes that the update was made.
o Please follow your local policy/procedure for escalating Rexis or
Prisma/clarify issues to the appropriately trained personnel or Rexis team.
How to properly classify a case as Inquiry vs Complaint vs Logistic

Claim vs Support Request
o Utilize the following definitions when determining if a case is an Inquiry,
Complaint or Logistic Claim.
Inquiry Any request by a customer/end user for information

concerning a product or technique, not related to an alleged
deficiency.
Complaint - Any written, electronic, or oral communication that

alleges deficiencies related to the identity, quality, durability,
reliability, safety, effectiveness, or performance of a device after it has
been released for distribution. This also includes reports in scientific
journals and significant labeling issues.
Logistic Claim - Issues that do not impact the performance and

functionality of the product, but are related to shipments from RD hubs
to Affiliates or direct shipments from RD hubs to customers/end-users.
Support Request Questions from Roche local and regional service

and support organizations related to end customer interaction. Typical
requests include (but are not limited to):
support in relation to install/ connect a device or system

support to configure a device or system
troubleshoot and repair a device or system
support to maintain a device or system
support to update or migrate a device or system
support to setup a customer specific application
support to find information (e.g. spare parts, documentation)
Documentation on a case
Only one quality issue described per case

o LCH are required to document only one issue per case. The case must be
classified as an inquiry, complaint, logistics claim or service request to
determine how it should be handled. Complaint cases must include the
rationale for actions taken within the case.
o LCH should properly identify/determine if PRI, PSI and pPHT criteria has
been met in every case.
o If many issues happen in parallel, for example, the instrument was not
working and a leaking tube was contained in the reagents box, a different
complaint should be opened for each issue, as the affected products are
different.
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How to properly document that the solution has been communicated to
the customer
o It is expected that the solution to the customers complaint is communicated
to them either verbally, via customer letter or email. It is required that
communication of this solution be documented within the local case as a Log
a note or Log a callor as an attachment.
Please use the following standardized phrase as the Subject of your log
note, log call or attachment: Solution was communicated to the
customer.
o The solution selected in the coding section of the affected products tab should
correlate to the solution communicated to the customer.
How to ensure the Problem Description is complete, clear and concise;

able to understand the issue provided
o The local case problem description should contain a clear/concise description
of the issue the customer is experiencing and troubleshooting performed by
the customer prior to contacting Roche. It should contain all relevant
information and tell a complete story as to the issue the customer is
experiencing.
How to ensure the case contains complete/relevant information and all

appropriate documents are attached
o All customer contacts and data obtained from the customer are documented
in CRM.
Test information, instrument files or instrument data that is received
from the customer/instrument shall be attached to the CRM case as a
case attachment(s).
Follow your local policies/procedures for attaching a file to your case.
o There should be a detailed explanation of how the data is associated to the
customers complaint and how the data validates the customer complaint.
o All attachments containing Protected Health Information are to have this
information blacked out prior to attaching the document to the CRM case per
HIPAA guidance and/or encrypted.
o Specific to the U.S., the edit function within a case entry (Log a Call or Log a
Note) should only be used to select the Send Notes To CN Chatter Feed
checkbox. No other edits should be made to the entry. If an edit is needed, a
Log a Note should be utilized to note any clarification to case documentation.
o LCH should not remove attachments from a case, unless they were attached to
the incorrect case and are being moved to the correct case. If an attachment is
removed a Log Note must be added to document the reason for removal. The
removal of an attachment is also automatically logged in the Case Attachment
History.
All attached documents that can be printed indicate "For internal use
only.
o All material created by the LCH to be printed within a Local Case or an

Escalated Issue should contain the text For internal use only. This would
apply to every Microsoft Powerpoint slide (.ppt, .pptx), Adobe Portable Data
file page (.pdf), Microsoft Word Document page (.doc, .docx.) or any other
document that can be used as a printed version attached to the Local and/or
Escalated Issue.
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Good Documentation Practices should be used throughout the case
o The case notes shall reflect an accurate and complete depiction of the
customer interaction specific to the customer inquiry or complaint.
o Documentation within the case should describe the issue the customer is
experiencing and troubleshooting performed by the customer prior to
contacting Roche, as well as, the troubleshooting performed with the
customer to resolve the issue. It should include a summary of what
information has been provided to the customer or what Roche personnel has
instructed the customer to do, in-order to determine the root cause of their
issue.
o It is the expectation that case notes, Log a note or Log a call are logged
at the time of the customer interaction whenever possible. If notes and/or
calls are entered after the fact an explanation and additional documentation
may need to be provided based on local policies and procedures.
o Good documentation practices (GDP) are essential for the generation of
acceptable quality complaint data, accurate complaint process indicators and,
very importantly, compliant, prompt, and thorough complaint investigations.
o High quality data leads to a better detection of trends in complaint process
data and product quality data by having a reliable and consistent baseline to
compare changes in the performance of the complaint handling process.
Unreliable data can result in trends or product quality issues that get
overlooked because there is not a reliable baseline to use as a model.
o A key to Good Documentation Practices is to consider these questions each
time you record your raw data:
Is it true?
Is it accurate?
Is it timely?
Is it legible?
Working on a case
How to handle duplicate cases created in CRM (REXIS/PRISMA Clarify)

o When duplicate local cases are created within the CRM, the duplicate case
should be obsoleted to the original. Follow your local policy/procedure for
obsoleting duplicate cases.
o When a duplicate escalated issue is created, if it has not yet been submitted
for evaluation, it can be cancelled using the cancel button. If however it has
already been submitted for evaluation, the GCH will have to close the case as a
duplicate to the original.
How to handle an already attached file in CRM

o LCH should not remove attachments from a case, unless they were attached to
the incorrect case and are being moved to the correct case. If information
relevant to a global investigation is attached to the local case, they should also
be attached to the global case in aurora as well.
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How to properly log all appropriate and relevant
information Products/batches/expiration dates/versions/serial number
in CRM (guidance)
o The Affected Product fields are used to identify Roche products associated
with a customer complaint.
o Multiple products may be listed when the complaint requires further
investigation and all are associated with the customer complaint. Enter at
least one Affected Product for all complaint cases (including those that are
being escalated for further investigation). The only exception is for complaint
cases that contain only an associated field service or workshop dispatch.
o Only one product should be marked as the Failure Causing Product. It is
critical that the appropriate failure causing product is selected as this dictates
which global CIR team will investigate the escalated issue.
o Every reagent must have a lot number entered, or the no lot number
checkbox ticked. Whenever an Escalated Issue (CN) is created, it is
appropriate to add #? to the lot # field of the local case and select the no lot
number checkbox, so the #? migrates into the Escalated Issue lot number
field.
o Properly logging all related product (serial #s and lot #s) allows for quality
trends to be modelled determining how various products are performing.
This is imperative to the evaluation process.
When is it appropriate to code affected products?

o It is best to not select the case description codes until you are ready to close
the case, as the code set selection may require updating to reflect the
appropriate field escalation.
o If you have escalated a case for further investigation to global entering the
affected products coding is required prior to escalation. However, be sure
that this information is updated based on the cause determined through this
investigation process.
How to properly code a local case and ensure that the codes used match
the root cause found - Coding definitions
o The case type is used to distinguish between Hardware, Software and
Application/Reagent cases. This information is important to route the case or
related service activities to the correctly skilled team.
o Ensure that the Code Set, Category and Cause are properly aligned with the
case description. If the problem description is referring to an assay
performance for example, hardware electronic system damaged should
not be selected. Also check that Not applicable was not the option selected.
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o The following are examples of a Code Set, Category and Cause that are
properly aligned with the case description.
Scenario 1: The customer called in stating they had received erroneous Vitamin D results on
one patient sample. The escalated issue investigation determined that the cause was related
to the integrity of the patient sample. The code set, category and cause below align
appropriately with this finding.
Scenario 2: The customer called in stating Lipase quality control was out of range running 2
standard deviations high. The escalated issue investigation determined root cause as being
carryover related which was resolved through cell rinse improvement and gear pump
pressure increase. The code set, category and cause below align appropriately with this
finding.
Scenario 3: The customer called in stating the false bottom tubes were not running on their
instruments. It was determined that the c8000 driver was sending the container type in the
wrong field. Through the escalated issue investigation the allegation was verified as a
software issue with the Cobas Infinity and a software update was being created to resolve the
issue. The code set, category and cause below align appropriately with this finding.
o See the CMG Local Case Coding Definitions for guidance here
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Escalation
How to properly identify when to escalate to AURORA

o Any case which cannot be solved locally, and all cases that meet the PRI/PSI
classification criteria, must be escalated to the responsible Global Case
Processing team (Case Investigation and Resolution (CIR) team or equivalent
organization) for investigation.
o Locally solved cases may include:

Inquiries where no further support from the global organization is
needed to answer the customer inquiry.
Complaints for which the alleged issue has already been escalated and
investigated or the investigation is in progress for which no new
escalation is needed.
Complaints where the alleged issue:
Was resolved through troubleshooting and/or product
replacement and/or service intervention AND the cause of the
alleged issue is not associated with a possible failure of the
product, labelling, or packaging.
Is due to user error but not due to misinterpretation of the
package insert / labeling.
Describes intentional off-label use and there is no alleged
product issue.
o Note: For a detailed guidance on the criteria for escalation, please refer to the
table attached at the end of the handbook.
How to properly identify if an Escalated Issue already exists that can be

linked to my local case
o When the Escalate Complaint button is clicked within a REXIS case, a new
window will prompt the user with already existing, open escalated issues that
could be related to their local case.
o Use this functionality in situations such as the following: One customer
account calls experiencing issues with loading the same lot # of reagent on
multiple instruments (i.e. wrinkled barcode label).
o This functionality allows you to create one Escalated Issue (CN) to investigate
the reagent issue and link it to the 6 local cases created against each
instrument.
How to properly cancel an Escalated Issue

o If the escalated issue was created in error, the LCH and LSO have the ability
to cancel the Escalated Issue by selecting the corresponding button as long as
it the Current Status is Opened (see below).
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This requires an electronic signature and an entry into the Comment
field before confirming your signature.
The Escalated Issue should be cancelled in a timely manner, as soon as
you become aware it is not required.
o If the Escalated Issue has already been submitted for evaluation, it cannot be
cancelled. You must follow the workflow, until the Escalated Issue is closed.
o If you do not have at the moment the serial/software/lot number, please enter
#?.
How to answer PRI/PSI questions within the Local Case
o The LCH should not set a case as PRI in the evaluation section in Aurora, this
should only be done by the Global Case Handler who owns the escalated issue.
o The LCH should only ever create a PRI/PSI within the local case. And does so
by answering the PRI/PSI determination questions based on information
alleged by the customer. A yes answer to one of these 4 questions will result
in a Q assessment being auto-generated within the local case, which should be
completed based on information provided by the customer.
How to properly answer the 4 questions in the PRI/PSI Determination

o Every complaint must be evaluated to determine if it contains an allegation of
one or more of the following categories:
Is there an Allegation of Death, Serious Injury or a Serious
Deterioration of Health?
Was the case reported to the authorities by the customer?
Is there an Erroneous Result?
Was there a Malfunction?
Evaluate the complaint to determine if there is an allegation that Death,

Serious Injury or a Serious Deterioration of Health actually happened
and involves a Roche distributed product
o Answer Yes:
If there is an allegation that Death, Serious Injury or a
Serious Deterioration of Health actually happened and
involves a Roche distributed product.
o Record details of exactly what happened.
Example: the laboratory technician fell in the laboratory next
to the cobas c501 machine and broke his leg
Example: In the central laboratory, the user spilled the
reagent cassette solution on their uncovered left arm. This
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contact triggered an allergic reaction that led to anaphylactic
shock subsequently causing death.
o Answer No:
If the issue could have happened.
o Examples of Serious Injury include, but are not limited to:

Results which caused patients to undergo inappropriate
treatment (was treatment received due to incorrect results? was
treatment not provided due to incorrect results? Was a
treatment changed due to incorrect results?) such as
transfusions, surgery, hospitalization for additional treatment,
or a change in their current therapy.
Harm to patient
Electrical shock while operating the analytical system or
accessory.
Burns: user was burnt while operating the analytical system or
accessory.
Allergic reactions
o Whenever you answer YES, the comment field is mandatory.
If this magic question is answered yes, the following questions should

be reviewed with the customer and answered in the Q assessment.
These additional questions support the assessment required by Safety Board and the
Regulatory Reporting Groups by:
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o Providing details on the nature/severity of the injury,
o Determining how the Roche product caused or contributed to the event.
o Information written in the comments field such as check local case, see
case notes, see attachments in local case will not be accepted.
Evaluate the complaint and determine if there is an allegation that the

customer actually contacted a regulatory agency/authority/notified
body to complain about a Roche product.
o Answer Yes:
Only if there is an allegation that the customer actually contacted a
regulatory agency/ authority / notified body to complain about a Roche
product.
Provide in the comment section the information of whom was contacted
and the date it was done.
o Answer No:
The customer has not actually contacted a regulatory agency / authority /
notified body but is threatening to do so.
The customer had contacted legal council
Evaluate the complaint to determine if there is an allegation from the

customer that there were incorrect or erroneous results meeting PRI
criteria according to the Annex 07a (for REXIS cases you can use
directly the Patient Comparison Tool) and a Roche distributed product
is likely to have caused/contributed to the allegation.
o All erroneous results generated by the device, whether reported from the lab
or not, are evaluated. Examples to consider include, but are not limited to:
1. Erroneous results comparisons meeting PRI criteria as outlined in
Annex 07a.
2. False positive or False Negative results meeting PRI criteria as
outlined in Annex 07a.
o When the customer reports erroneous results, please determine how the
customer determined the results may have been erroneous. Examples
include, but are not limited to:
1. Results did not match the clinical picture of the patient.
2. Previous results from the patient indicated the result may not be
correct.
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These additional questions support the assessment required by Safety Board and the
Regulatory Reporting Groups by:
o Providing specific details on the results meeting PRI criteria and potential
impact to the patient.
o If I answer YES to there are erroneous results, I should answer YES to
questions 1 and 2.
o Determining the potential for a public health threat.
Evaluate the complaint to determine if the device malfunctioned in a way that

would be likely to cause or contribute to death or serious injury, if the
malfunction were to recur.
o Important! This is the only question where it is acceptable to consider if the

issue could have led to serious consequences. The allegation that a
malfunction of a Roche product actually led to death, serious injury or a
serious deterioration of health is already answered in question 1.
o Answer Yes:
If the malfunction were to recur, could lead to death, serious injury
or a serious deterioration of health.
o Answer No:
If there were erroneous results due to some type of malfunction
(example: Bent probe, Washing problem, etc..) but the erroneous
results do not meet PRI criteria as defined in the Annex 07a. If
there were Bent probe, Washing problem, motor broken,
mechanical problem, etc.. only and no erroneous results meeting
PRI criteria as defined in the Annex 07a.
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For the follow up questions please record details of exactly what happened
o Examples include but are not limited to:
Electrical issues which have or may create a hazardous environment, such

as fires, explosions, or electric shock which caused the user(s) to evacuate
or seek medical attention.
Evidence of fire, burning, or physical damage to the device due to
excessive heat (not including smoke or noxious odors) including but not
limited to the appearance of melted plastic, charred plastic or metal parts,
charred circuit boards
Smoke, noxious odors or chemical vapors in sufficient quantities which
requires evacuation or other similar action to prevent potential injury to
the user. Odors and chemical vapors are not considered PRI unless the
user(s) sought medical attention due to inhalation, or the odors (or
chemical vapors) caused evacuation or other similar action to prevent
potential injury to the user(s).
Allegations of leaking instruments only require classification as PRI/PSI if
the leak did cause or contribute to a death or serious injury.
Other reported problems of hardware (e. g. instrument, analyzer,
handheld, accessories, disposables), leading or contributing to one or
more events/incidents with direct and/or indirect harm and leading or
contributing to potential events/incidents with direct and/or indirect
harm.
Software bugs (malfunctions) in Instrument Software, System Software
and Information Solutions that lead to:
o Sample mismatch
o Incorrect Patient ID
o Incorrect Surname
o Incorrect Patient Birth Date, Age, or Gender
o Incorrect values
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o Erroneous flags
o Erroneous alarms
Wrong or missing information on reports
Incorrect/missing comment has/may have a critical impact on medical
decision making. Examples include (but are not limited to)
Comments in the blood depot module are lost or truncated (comments are
relevant for the correct selection of donor blood).
Lost or truncated comments which contain information on flags and/or
alarms being relevant for reliability and interpretation of associated
results.
Comment field contains results. A result, generated, calculated and added
by the software or received from the instrument interface.
Rule Engine and similar result transformation algorithms causing
problems.
Other reported problems of hardware (e. g. instrument, analyser,
handheld, accessories, disposables), leading or contributing to one or
more events/incidents with direct and/or indirect harm and leading or
contributing to potential events/incidents with direct and/or indirect
harm.
Automatic creation of Escalated Issue when case identified as PRI/PSI

o If the local case meets PRI/PSI criteria, upon submission of the Q assessment
for LSO approval, the CRM will automatically generate an escalated case
(CN). Therefore, it is imperative that if an escalated case already exists within
the local case that this escalated case (CN) is documented in the complaint
field within the Q assessment before submitting it for LSO approval.
Otherwise, a duplicate escalated case (CN) will be created within the local case
and Aurora and will need to be cancelled.
o A duplicate CN can be cancelled only when in an Open workflow status. The
LCH should select the cancel button in the upper right hand corner and will
need to provide rationale for cancelling the CN once selected.
o If the global case needs to be cancelled after it has been submitted for
evaluation, this responsibility will fall on the GCH to process.
How to create a PRI/PSI assessment after an Escalated issue has already

been created, either by request of GCH or when additional information is
provided that meets criteria.
o Properly creating a PRI/PSI assessment after an escalated case has already
been created is imperative to ensure that a duplicate escalated issue is not
created when the PRI/PSI assessment is submitted for LSO approval.
o When the LCH is notified by the GCH that PRI/PSI criteria has been met or if
new information has been obtained indicating a PRI/PSI is required, the LCH
should create the PRI/PSI Q assessment within the local case.
o Appropriately answer the 4 PRI/PSI questions per the criteria that has been
met. If this is not clear clarify this with the GCH before taking further action.
o When one of the 4 PRI/PSI questions is answered Yes the Q assessment will
automatically be generated within Rexis.
o Select the Q assessment within the local case. Enter the already created
escalated case number (CN-xxxxxx) in the complaint field located under the
local case field in the assessment and then enter the Become Aware Date.
Then select the save button located at the top of the screen above the green
status line.
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o Answer the follow-up questions present in the assessment based upon the
information provided by the customer. These follow-up questions are directly
related to the PRI/PSI question that was answered Yes within the local case.
o Once all questions are answered appropriately, select the save button below
the questions and submit the assessment for LSO approval.
How to handle an escalated case when LCH is not available.

o When the LCH is not available (Vacation, Leave, or Sick) a proxy should be
assigned either by the LCH themselves prior to leave, via leadership or
designee within the local group monitoring these cases. We need to ensure
that in the LCH absence follow-up and/or closure is not neglected. Once the
LCH proxy is determined, the Affiliate User field within the Escalated Issue
should be updated accordingly. Follow your local policy/procedure for
handling cases when the LCH is unavailable.
Aurora escalated case coding definitions

o The Aurora escalated case coding should align directly with the local case
coding. Ensure that the Error Code 1 and Error Code 2 are properly aligned
with the case description.
o Also check that Not applicable was not the option selected.
o See the CMG Local Case Coding Definitions for guidance here
How to handle missing information (Patient data)

o Every attempt should be made to gather all information relevant to the
customer complaint, which can include patient data. On occasion, this
information may be unavailable at the time of the customer contact or the
customer may decline to provide it. The expectation is to make 3 attempts to
gather this information, if originally unavailable. If the customer declines to
provide the information or if we are unsuccessful in obtaining the information
after 3 attempts, we will document this appropriately in our case notes and
inform the GCH to proceed with their investigation utilizing the information
provided.
o Reference guidance below, in the escalation section, How to properly
complete the Escalated Issue Patient and Escalated Issue Test
Results section of the escalated case when a PRI/PSI has been
identified.
o Also see here for additional guidance
How to appropriately handle Patient Identifiable Data (PID)

o Patient Identifiable Data is any information relating to an identified or
identifiable natural person; being one who can be identified, directly or
indirectly, in particular by reference to an identification number or to one or
more factors specific to his or her physical, physiological, mental, economic,
cultural or social identity. Any information which, if taken together, could
allow the patient to be identified is considered PID.
o Data should be anonymized at the Affiliate/local level prior to escalation of
case information to global functions, meaning the file or information provided
to global does not identify an individual and there is no reasonable basis to
believe that the information can be used to identify an individual.
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o Anonymization should not be done if it will result in corruption of a data file
or the data is considered necessary for case handling activities (e.g., patient
age, gender, weight) or regulatory reporting (PRI cases reported require the
name, address, and patient demographics).
o When handling patient data, both local and global functions must adhere to
the policies of their country regulatory bodies (e.g., United States HHS and
United Kingdom NHS).
How to ensure the problem description in the Local Case matches the
Escalated Issues problem summary
o In a REXIS Case, go to the section Description Information, and then check
Subject, Description and Allegation.
o In a REXIS Case, go to the section Escalated Issues and see the E.I. CN
number
o If you click the CN number in REXIS, you will be redirected to that Escalated
Issue in Aurora. Go to the section Product Information and Problem
Description in order to see if the information contained mirrors the one in the
local case.
o It is imperative to the investigation of the complaint that the Problem

Description in the Local Case mirrors the Problem Summary in the
Escalated Issue (CN). This allows for efficient and accurate assignment
of the investigation to the appropriately trained Global Case Handler.
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Print Comment:
Mandatory fields within the escalated issue
o Product Information and Product Search and Selection: This

information transfers to the CN from the Affected Product section of the
CAS but should be reviewed and edited as required.
a. Verify a product has been indicated as the suspected Error Causing
Part (ECP). If this did not transfer from the CAS, select the ECP.
b. All of the Affected Products must be entered accurately.
c. Add the instrument to the affected product section only if the
instrument is the ECP. Use care when selecting your ECP as it
directs the CN to a specific investigative team. .
d. Every reagent must have a Lot Number entered, or both the No Lot
Number checkbox selected and #? in the Lot Number field.
e. Every IT product must have a Software Name and Software
Version number entered.
f. If any of this information (Instrument serial #, Reagent Lot # or
Software Name/Version) is unknown, enter #? in the appropriate
field.
g. Save Changes in the Product Search and Selection section
saves the information in that section only. The Save at top or bottom
of the CN will be used later to save changes to the CN in total.
o Error Information section: Select Error Code 1 and Error Code 2 from the
drop down lists.
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o Problem Summary section: In the Problem Description field, enter a
detailed explanation of the issue. It is recommended that you copy and paste
the full Problem Description statement directly from the template
information entered in the CAS and include any additional templates needed
for the escalation.
o For a detailed information on what information is needed for Escalated Issues
Evaluation by CIR, please find the RMS (RTD/RMD/RSS) & CPS Reagents &
Systems Checklist within Hot News in GRIPS for every product. Be sure to
follow your local policy/procedure regarding data collection.
o In the event that relevant information is available but not documented
elsewhere in the Escalated Issue available fields, the Problem Description
should describe the issue in detail and may provide the following:
Reason for escalation, request.
Present or past related similar issues from the same customer? CN-#?
Affected product, GMMI #, Lot #, Serial #, Version #, Application
number ACN #.
Instrument type, serial # and configuration, e.g. modules.
Maintenance status of the instrument, date of last service
maintenance.
Since when does the problem occur? Frequency of occurrence?
Date and time of event/ error.
Which other applications/tests are run on the instrument (including
non-Roche tests)?
Are other tests/ applications/ samples affected?
Sample/ specimen types and sample tube/ cup information.
Data flags/ alarms/ error messages at time of event.
Analyzers used for repeat testing: Identical sample re-run on identical
instrument versus new-drawn sample run on another analyzer?
Calibrator information, setpoints, target values
Performance of Quality Control materials, Roche and non-Roche?
Troubleshooting activities performed? / Affiliate actions taken?
Outcomes?
Were instructions followed concerning handling, stability, transport
and storage conditions of materials?
Are the local pre-analytical procedures suitable? (e.g. centrifugation)
Sample-specific information, e.g. serum indices (H, I, L), patient
medication, diagnosis.
o Information written in the Escalated Issue such as check local case, see
case notes, see attachments in local case will not be accepted.
o Summarize in your own words the reason for escalation in the Problem
Description.
o Dates section:
Dates Defined:
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Date of First Contact: Date that customer contacted any Roche
personnel regarding an event.
Date of Event: Date communicated by the customer as the actual
date the event occurred.
Become Aware Date: When any employee has acquired
information reasonably suggesting a PRI/PSI event has occurred.
Enter the Become Aware Date only for PRI/PSI cases (should align
with the BAD documented in the Q-Assessment and Local Case).
Verify Date of First Contact.
Enter the Date of Event.
o If the CN is created automatically, the Affiliate User is populated. If

Affiliate User is blank, it must be filled in with your name.
o General Information section: Select Info Source and Reason for

Escalation from drop down choices.
o If the escalation is for a PRI/PSI, continue with the next steps for the
Escalated Issue Patients and Escalated Issue Test Results sections.
o The Affiliate Actions Taken section is only mandatory for RTD. This
section helps the GCH start to understand the troubleshooting already
performed at the local level. Follow local Aurora training received within your
affiliate with regards to this section.
How to handle "attachments" from the Rexis case, when an escalated

case is created.
o The GCH does not review the local case. Therefore, it is the responsibility of
the LCH to attach all relevant attachments from the local case to the Escalated
Case within Aurora. These attachments should be attached via Chatter for
review by the GCH.
How to properly complete the Escalated Issue Patient and Escalated

Issue Test Results section of the escalated case when a PRI/PSI has been
identified.
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Print Comment:
o Certain patient information previously recorded in FT07 will now be captured
in Escalated Issue Patient section and is mandatory for PRIs. Also if the
field "Is PRI" is yes and the field "Erroneous Results on the related REXIS
case is yes, the escalated issue that is in status "Open" can only be submitted
for evaluation when at least one record exists in the related list "Escalated
Issue Test Results".
o Complete one Escalated Issue Test Results per pair of values that triggered
the PRI and one Escalated Issue Patients for each patient involved in the
PRI.
Create a new Escalated Issue Patient section by clicking on the

button.
Select Information Requested but not Provided by Customer

to place a check mark in the box, if there were no patients involved in
the event or the customer refused to provide patient information.
Note: Selecting this box will eliminate all additional questions in the
Escalated Issue Patient section.
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Print Comment:
Note: If there were no patients involved in the event then in addition to
checking Information Requested but not Provided by Customer in
the Escalated Issue Patient section, add a comment in the Escalated
Issue (CN) Problem Summary section stating patient information is not
applicable.
Select appropriately based on your business area Does the

Escalated Issue involve Roche CPS products? (CPS =
Centralized and Point of Care Solutions)
Complete Patient Demographics if patient demographic

information is available. The Comments text box can be used to add
any comments or explanation. Do NOT enter patient name. You may
enter Sample ID or some other identifier, but do not use any part of
the patient name.
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Print Comment:
Complete Medical History. The Other Medical History, Comment
Autoimmune Disease and Comment Malignant Disease text boxes can
be used to add comments or explanation.
Complete Medication if patient medication information is available.

The Other Medication, Indication for Anticoagulation and
Therapeutic INR Range text boxes can be used to add comments or
explanation.
Complete Medical Devices if patient medical device information is

available. The Other Medical Devices text box can be used to add
comments or explanation.
After Patient Demographics information is saved, the software will

assign the patient a Patient ID which will start with PA. The Patient
ID will be seen at the top of the Escalated Issue Patient section, in
the Patient Demographics area, and on the CN. There will be one
Patient ID for each Escalated Issue Patient section.
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Print Comment:
Repeat this process for each patient.
Create a new Escalated Issue Test Results section by clicking on
the button.
Complete all fields.
Note: Guidance is provided below for the various fields.
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Print Comment:
Sample Description: Enter the two test results used to
determine the complaint meets PRI criteria. Examples include the
highest and lowest value, the normal value and the erroneous
value. If multiple assays were involved, provide the assay name for
the result.
Value: The test result value believed to be erroneous (discrepant
result).
Units: Units for the assay results.
Sample Number: Sample identification, if available. Do NOT
use patient name.
Comments/Additional Information: Enter the rerun result, if
available, or any other additional information.
Click Save after all applicable questions are answered.
After the Escalated Issue Test Result information is saved, the

software will assign this result a Test Results Name which will start
with TR. The Test Results Name will be seen at the top of the
Escalated Issue Test Result section, in the Escalated Issue Test
Result Detail and on the CN (see next step). You will have one Test
Result Name for each Escalated Issue Test Result section.
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Print Comment:
Repeat this process for each value (or set of values) triggering the
PRI/PSI.
How to properly submit an Escalated Issue for evaluation

o The age of an Escalated Issue starts from the day it is opened, not the day it
was submitted for evaluation, so it should be submitted as soon as possible.
o Always verify that the escalated issue is submitted for evaluation by clicking
on the corresponding button (see below). It will not be visible to any Global
Case Handler until it is submitted.
o Expected Time Frame for escalations

< 2 days for PRI/PSI yes
< 5 days for PRI/PSI no
< 5 days for Logistic Claims
o Follow your local policy/procedure for handling cases when the Escalated
Issue.
How to manage timely updates on the Escalated Issue

o The expectation is that upon request for additional information from the
Global Case Handler the LCH should respond within 24-48 hours. If the LCH
is reaching out to the customer for additional information and is unsuccessful,
this information should be shared with the Global Case Handler so they are
aware that the LCH is attempting to gather the requested information.
o It is critical that you provide these updates on escalated issues in a timely
manner in order to avoid new information being added to a case that is ready
for closure.
How to properly use Chatter feed in REXIS/AURORA or Communication

history in PRISMA
DONT DO
Post anything you would not want Participate by asking/answering

your HR team / executives /auditor / questions and sharing information
inspector to read Keep posts brief and relevant to work
Write long-winded posts or use to Use to address a wider audience and
replace an in-person conversation get feedback
Share or discuss negative feedback on Use groups rather than email
individuals or teams distribution lists for collaboration
Post confidential information on Think about who can see your post
profiles or public groups (anyone who is following a person or
Post personal messages that are not a record can see its Chatter posts)
relevant to our business
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Print Comment:
How to properly use Hashtags within Chatter.
o Use the # (Hashtag) to associate the post to other updates and comments on
the same subject:
Add a # in front of a word/topic
o To see the same topic like other users:
Click the Topics link to view related posts.
Note: Hashtags are used within Roche to tag and track specific topics such as
parent cases.
How to properly close an Escalated Issue

o Be sure to follow your local affiliate policy with regards to the Escalated Issue
closure process and customer follow-up, if required.
o Once the Escalated Issue is in Peer Review Approved status it is ready for
closure.
Closure should be performed in a timely manner, < 5 days from initial
notification that the case is ready for closure.
If no action is performed, reminders will be sent to all appropriate
parties.
o Complete the affiliate satisfaction survey.
It is intended to evaluate the Timeliness, Quality and Usefulness of the
Escalated Issue evaluation/investigation.
It should not be used to rate the products performance.
o To accept the global closure and close the Escalated issue, select the
corresponding button.
The Escalated Issue status will change to Closed.
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Print Comment:
o To reject the global closure, you will first have to enter a comment in the
Affiliate Rejection Rationale field before selecting the button.

o The Escalated Issue status will change to Case Summary and Closure and
the GCH will be notified.
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Print Comment:
CRITERIA FOR ESCALATION FOR AFFILIATE CALL CENTERS
First determine if the event meets PRI criteria. Refer to Annex 07 for detailed guidance on whether
the issue meets PRI criteria.
All PRI/PSI events MUST be escalated without exception.
DO NOT
Foruse
all this
otherdocument for any
complaints, complaint
refer that meets
to the guidelines inPRI
the criteria .
table below to determine if case escalation is warranted:
Escalation Reason for Description Examples to escalate (but are Examples that should not be
criteria Escalation in not limited to): escalated
SFDC
Sample Highly complex Allegation of a sample Discrepancy in result output. Do not escalate as a sample related
related issue where specific issue that can Apparent but unknown cross- issue if:
performance cause cannot be be replicated with reactivity. Local investigation determines
issue/discrepa identified or either the original Apparent but unknown issue is due to instrument
nt results supporting sample or an interference. malfunction or local pre-
Roche artificially prepared Local sensitivity or specificity analytics/handling.
documentation sample. not matching product claims** Results are not reproducible
does not exists So far, unknown if matrix Performance issue is due to
to explain the effect is the cause of the use outside of the product
cause of the discrepancy. performance claims/intended
discrepancy Survey sample not recovering use of the Roche product ( i.e.
no QN/SN or correctly and is repeatable off-label sample type or
approved (issue is not due to sample sample with a concentration
workaround or specific reasons e.g. due to a below the LOD of the test)
documentation known interfering additive **) Exception to this: If there is
indicating not Customer claims that a harm to the patient or user,
to escalate particular product insert claim escalate. Refer to PRI/PSI
(e.g. dilution, precision, criteria in GSOP-15.
stability, linearity, etc.) or Customer not following
product specification is not instructions for use (off-label
met. ** protocol) Exception to this:
Erroneous or biased sample If there is harm to the patient
results that are not detected as or user, escalate. Refer to
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Print Comment:
controls recover within range. PRI/PSI criteria in GSOP-15
(In such cases the patient
clinical picture may indicate an
issue or non-Roche controls
may show a shift.)
Other high complexity Allegation of Examples Information/solution is
performance no QN/SN or repeatable Controls/CalChecks available in GRIPS *
related defect approved performance related repeatedly recover outside Performance issue can be
(reagents, workaround or issue that is: claimed acceptance range corrected through local
calibrators, documentation (even upon re-calibration) instrument Roche approved
controls) indicating not Not a sample Roche controls (accuracy maintenance/troubleshooting
to escalate specific issue and controls) recover outside local or other Roche approved
is reproducible regulatory requirements. documented solution.
A particular Unable to run due to failed Performance issue due to
product claim (e.g. calibration or QC and no operator error, e.g. product
dilution, precision, instrument issue is known. A handling or storage.
stability, linearity, new shipment of reagent, QC Any off-label use which is
etc.) or or calibrator did not resolve directly related to the failure
specification is not the issue.** observed. Exception to this:
met and customer Controls are within expected If there is harm to the patient
is unable to run.** range but patient result does or user, escalate. Refer to
not match clinical picture. PRI/PSI criteria in GSOP-15.
Patient result does not match Business Issues.
another manufacturers Performance issue caused by
method. exposure to high or low
temperatures during local
transport (e.g. frozen beads).
Software & IT high complexity Allegation of a Reboot does not fix issue. Irreproducible event (must
related no QN/SN or software related Software bug is reproducible. have attempted to reproduce
performance approved issue Issue is not already known and event in same environment as
defect workaround or investigated. initial event and unable to do
documentation No workaround available. so).
indicating not to
escalate
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Print Comment:
Physical defect no QN/SN or Allegation was Any product that has a defect Physical damage occurred
approved determined to have that is a physical attribute during shipping (follow your
workaround or been caused by a effecting performance and is local process for handling a
documentation deficiency in a Roche not due to local logistics complaint).
indicating not to product and can be shipping/handling Agglutinated/frozen beads
escalate represented to the Leaking products without any performance issue
global case handler (or Damaged/unreadable - likely due to shipping (follow
investigator) through a labels/barcodes/ product/parts your local process for handling
written explanation, Missing/incorrect a logistics complaint).
photograph and/or components/labels or parts Allegation is due to missing
return of the affected Incorrect number of documentation (i.e., package
product. components in the kit insert, Barcode Card or other
Agglutinated/frozen beads label sheet) that can be
affecting performance of the downloaded from GRIPS (or
product equivalent). *
Page | 33
Print Comment:
Labeling / no QN/SN or Allegation was Erroneous information on
documentatio approved determined to be due labels / documentation / Allegation is due to a missing
n defect workaround or to incorrect, erroneous Method Sheets / Value Sheets labeling component (i.e.,
documentation and/or missing / Manuals / Package Inserts package insert, Barcode Card or
indicating not to labeling or related and no updated information other label sheet) that can be
escalate documentation. available in GRIPs.* downloaded from GRIPS (or
Missing/incorrect equivalent) or is locally
documentation* available and can be provided
Lacking or incorrect download to customer AND replacement
files (check with local contacts product does not have any issue
if it is a local issue. If files have and the issue appears to be
not been provided in GRIPs isolated.
then escalate)*
Error in product information
posted on the Roche Internet
(check whether update
available on GRIPs.)*
Customer customer unable Local troubleshooting Replacement of parts and/or N/A

unable to run to run has been exhausted product does not eliminate
and it has been performance issue.
determined that there Chronic performance issue.
is no viable work
around available for
customer to continue
using equipment or
reagent.
Page | 34
Print Comment:
Management Performance is Local management BioRad or other Non-Roche Requests for product
request not outside of (e.g., Local Safety controls (precision controls) performance improvement
Roche Officer, Affiliate recover systematically outside Any case of off-label use
specifications Quality Head, Call acceptance range in several Exception to this: If there is
but considered Center Management or customer sites; QC harm to the patient or user,
business critical Field Service manufacturer cannot solve the escalate. Refer to PRI/PSI
performance Management) requests issue; several customers and criteria in GSOP-15.
that the CIR escalation of issue. Key Accounts affected & Business Issue that does not
could potentially Roche business is at risk. relate to a performance issue.
investigate. Local key account failed in
high complexity external survey & local Business issue-requests for
measures did not solve the change to
issue. specifications/design of a
Publication on the product or information
performance of a Roche requests/questions regarding
product. products that are not sold in
that country.
Case Escalation Global case handler Any of the below, when requested N/A
Investigation requested by requests creation of by Case Monitoring and
and Case Separate global Governance (CMG) or CIR for e.g.
Resolution Investigation cases to record for trending or prioritization
request and Resolution multiple purposes
escalation (CIR) reoccurrences of QC recovery for a particular
same issue. combination.
Separate global Failed calibration, particular
cases for an event combination.
that different CIR On-board or other stability
members will work issue.
on. Packaging/labelling/shipping
Issue that the CIR issue.
learned about, but Elevated number of local
no global case was complaints identified by
submitted yet by the trending, without sufficient
originating country. explanation
Instrument, Defect Instrument failure Replacement of parts and/or Issues are fixed with service
workflow or or alarms that product does not fix the issue. and maintenance actions on the
Page | 35
Print Comment:
equipment high complexity impede the normal affected
related issues function of an instrument/equipment.
no QN/SN or instrument or Information/solution is
approved reagents ** available in GRIPs*.
workaround Performance issue due to
available or operator error/handling.
documentation Any case of off-label use which
indicating not is directly related to the failure
to escalate observed. Exception to this:
If there is harm to the patient
or user, escalate. Refer to
PRI/PSI criteria in GSOP-15.
Disposables Defect Disposables cannot Disposable is out of specifications Disposable is not as expected but is
be used as intended Examples: due to damage during shipping
no QN/SN or The defect is Closed tips Outer cardboard box damaged.
approved repeatable. Cut tips Intended change in product box
workaround Contamination of any kind design.
available or within sealed disposable pack
documentation Cups with holes in the bottom Specifically excluded are:
indicating not allegations due to shipping
to escalate damage. (Follow your local
process for handling a logistics
complaint) Exception to this:
If there are erroneous results or
harm to the patient or user,
escalate. Refer to PRI/PSI
criteria in GSOP-15.
Spare Parts / Defect Spare Part not Spare Part out of specifications Specifically excluded are:
Accessories working as intended and there is a risk for allegations due to shipping
no QN/SN or The defect is erroneous results. damage. (Follow your local
approved repeatable (the process for handling a logistics
workaround or replacement shows complaint).
documentation the same defect).
indicating not
to escalate
Page | 36
Print Comment:

Local Case Handling Best Practices Unlocked

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Global Group: Global Complaint Management

Signed By: dillonbj (Jennifer Dillon-Beem {DNPC....2846})

Signed By: kuhsep (Philipp Kuhse {DEGSSD..6195})

Signed By: moltenig (Giorgio Molteni {DEIR....1625})

Signed By: pinderr (Robert Pinder {DQMC....6019})

Title: Local Case Handling Best Practices Document Number: 0000000000001200000242322

Signed Date: 05-Jul-2017 16:21:01 (UTC)

Title: Local Case Handling Best Practices Document Number: 0000000000001200000242322

00 First release Date of approval

How to start a local case by searching for the serial number

How to create a case without a customer/account number

How to handle multiple serial numbers, account numbers for a customer

How to properly classify a case as Inquiry vs Complaint vs Logistic

Inquiry Any request by a customer/end user for information

Complaint - Any written, electronic, or oral communication that

Logistic Claim - Issues that do not impact the performance and

Support Request Questions from Roche local and regional service

support in relation to install/ connect a device or system

Only one quality issue described per case

How to ensure the Problem Description is complete, clear and concise;

How to ensure the case contains complete/relevant information and all

o All material created by the LCH to be printed within a Local Case or an

How to handle duplicate cases created in CRM (REXIS/PRISMA Clarify)

How to handle an already attached file in CRM

When is it appropriate to code affected products?

How to properly identify when to escalate to AURORA

o Locally solved cases may include:

How to properly identify if an Escalated Issue already exists that can be

How to properly cancel an Escalated Issue

How to answer PRI/PSI questions within the Local Case

How to properly answer the 4 questions in the PRI/PSI Determination

Evaluate the complaint to determine if there is an allegation that Death,

o Examples of Serious Injury include, but are not limited to:

o Whenever you answer YES, the comment field is mandatory.

If this magic question is answered yes, the following questions should

Evaluate the complaint and determine if there is an allegation that the

Evaluate the complaint to determine if there is an allegation from the

Evaluate the complaint to determine if the device malfunctioned in a way that

o Important! This is the only question where it is acceptable to consider if the

o Examples include but are not limited to:

Electrical issues which have or may create a hazardous environment, such

Automatic creation of Escalated Issue when case identified as PRI/PSI

How to create a PRI/PSI assessment after an Escalated issue has already

How to handle an escalated case when LCH is not available.

Aurora escalated case coding definitions

How to handle missing information (Patient data)

How to appropriately handle Patient Identifiable Data (PID)

o It is imperative to the investigation of the complaint that the Problem

o Product Information and Product Search and Selection: This

o If the CN is created automatically, the Affiliate User is populated. If

o General Information section: Select Info Source and Reason for

How to handle "attachments" from the Rexis case, when an escalated

How to properly complete the Escalated Issue Patient and Escalated

Create a new Escalated Issue Patient section by clicking on the

Select Information Requested but not Provided by Customer

Select appropriately based on your business area Does the

Complete Patient Demographics if patient demographic

Complete Medication if patient medication information is available.

Complete Medical Devices if patient medical device information is

After Patient Demographics information is saved, the software will

Complete all fields.

Note: Guidance is provided below for the various fields.

Click Save after all applicable questions are answered.