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Software Validation Workflow in TrackWise
Interfaces with Livelink
Regina Rohe, Director Validation
Lora Cox, Manager, QA/QC Automated Systems
Jenna Woodhead, Sr. Software Quality Engineer
bioMérieux
Paola DePaso
Solutions Consultant
Sparta Systems, Inc.
Agenda
 Company Overview
 Problem
 Solution
 Benefits
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Company Overview
 bioMérieux is a France-based company that specializes in the field of in-vitro
diagnostics for medical and industrial applications.
 The Company designs, develops, manufactures and markets systems used in
clinical applications, such as for the diagnosis of infectious diseases, and
industrial applications, such as for the analysis of industrial or
environmental samples.
 Its diagnostic systems are comprised of reagents required to conduct
biological tests, instruments used for automated testing at variable
throughputs, and software used to process and interpret the results of
biological tests.
 bioMérieux is present on five continents, in over 150 countries, with a
network of distributors and approximately 40 international subsidiaries and
14 Manufacturing sites.
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Architecture
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Process Overview
URS
UAT
Trace Matrix
Including
21 CFR Part 11
(IQ/PQ)
(100% traceability)
Test Cases
Objective Evidence
Anomaly Reports
Val Plan
Val Summary Report
Validation
+
Trace Matrix
(100% traceability)
FRS
Verification
(configuration)
Verification
Documents
(OQ)
System Risk
Assessment
Documented
Code Review
Code
(as required)
+
Training
+
SOP’s
+
Change Control
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Problem: Performing Validations in a Global
Environment
 Validations performed on paper. GREEN
 All performers not located at the same site.
 Approvals were manual and required scanning/faxing back to originator.
 Executed test cases required scanning/faxing to the test case reviewer.
 Execution problems were not caught early.
 Time zone differences
 Reduced travel costs
 Reduced QA overhead
 Reduced Validation cycle time
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Problem: Performing Validations in a Global
Environment
Performance of a large global validation on paper would:
 Be very slow
 Be very painful
 Not allow us to monitor validation activities remotely
 Impact overall project timelines
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Solution: Phase 1
Create an application to perform Validations electronically.
 Create it quickly
 Keep the scope small
 Must be 21 CFR Part 11 compliant
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Electronic Signatures
Electronic Records
Security
Audit Trail
 Includes Validation Number, Protocol, Test Case, Anomaly Report, and
Summary Report
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Solution: Phase 2
Enhance existing functionality:
 Added a Requirements Specification Workflow
 Added the ability to attach a Validation Plan
 Added a Traceability Matrix Report
 Added flexibility and improvements to allow usage in other areas
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Validation Process Workflows
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Validation Process Workflows
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Requirements Specification Workflow
 User or Technical
 Requirement Specification is an attached Word document with Livelink in
the background
 Approvals take place electronically in TrackWise
 Approvals are scheduled based on field values
 Requirements linked to Test Cases by a Reference Record field
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Validation Number & Plan Workflow
 Used to launch a Validation
 Automatically generates the validation number
 Ability to attach a Validation Plan
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Plan is optional
Plan is an attached Word document with Livelink in the background
Approvals take place electronically in TrackWise
Approvals are scheduled based on field values
 Package contents list with a justification for any items not included in the
Validation package
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Protocol Workflow
 Linked to the Validation Number as a child record
 Protocol # and System/Software information are carried down from the
parent record
 Can be IQ, OQ or PQ protocol
 Protocol is an attached Word document with Livelink in the background
 Approvals take place electronically in TrackWise
 Approvals are scheduled based on field values
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Test Case Workflow
 Linked to Protocol as a child record
 Created, approved and executed in TrackWise
 Utilized grid fields for test steps
 Permissions controlled by person field values
 Notifications used throughout to notify testers, approvers and originators of
waiting activities
 Screenshots and other objective evidence can be attached
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Test Steps: Grid Field Example
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Traceability Matrix Report
 Used when the Requirement Specification and Test Cases are stored in
TrackWise
 Added fields to Test Case to link to Requirement Specification
 Traceability Matrix Report linking Requirement to Test Case can be
automatically generated and attached to the Protocol for approval
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Anomaly Report Workflow
 Linked to the Protocol or Test Case as a child record
 Created and approved in TrackWise
 Permissions controlled by the Originator, Analyst and AR Approver fields
 Notifications used to notify individuals of waiting activities
 Allows for any Anomaly attachments
 Keeps track of types of Anomalies
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Summary Report
 Linked to the Validation Number as a child record
 Protocol # and System/Software information are carried down from the
parent record
 Summary Report is Attached Word document with Livelink in the
background
 Approvals take place electronically in TrackWise
 Approvals are scheduled based on field values
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Document Management System (Livelink)
 All attachments (e.g. Plan, Requirements Specifications, Protocols, Summary
Reports, AR attachments, Test Case objective evidence/screenshots) are
attached via TrackWise, but actually stored in Livelink.
 Folder structure and folder names automatically generated based on field
values
 Document link can be removed from PR, but documents cannot be deleted
from Livelink
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Coordinator
 Used to automatically schedule individuals for required approvals based on
person field values.
 Send notifications to originators, approvers, reviewers and testers.
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Reports
 Anomaly Report
 Test Case Report
 Traceability Matrix Report
 Export data for statistics and trending (e.g. breakdown of Anomaly types)
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Dashboards
 Real time picture of Validation status
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Test Cases waiting for Approvals
Test Cases in Execution
Test Cases in Review
Total number of Anomalies
etc.
 Provides quick link to specific records
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Compliance
 Security
− Controlled both field level and document level security by field values
 Audit trail captures all changes to values
 Electronic Signatures
 Attachments stored in Livelink cannot be deleted by the user.
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Benefits
 Real time overview of Validation activities
 Faster approval time for documents
 Faster review of Test Cases and documents
 People do not need to be at the same site. Validations can be created,
executed and approved remotely from any site.
 Faster correction of Validation execution errors before they continue
 Reduced documentation errors
 Audit trail of changes
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Benefits
 Common templates aligned with the IS verification templates
 Standard Validation workflow can be adapted by other validation processes.
 Ability to re-use existing validations using the copy functionality (regression
testing, periodic revalidation, etc.).
 No scanning of documents into Livelink by Doc Control.
− Easier retrieval of executed Validation documentation
 GREEN – paperless (Interfaced with Livelink for Documentation storage)
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Benefits
 Validation – Verification workflows were originally designed for and used in
Non-Product Software Validation
 Expanding Usage to the following validation – verification areas:
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Cleaning
Environmental
Equipment
Infrastructure
Process
Test Method
Utilities
 Trialing paperless validation using a tablet PC
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Questions?