Testing Computers Systems for FDA/MHRA Compliance
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There is no substitute for extensive testing when it comes to IT systems. Recognition that problems are easier and cheaper to fix before the system is in use (rather than after), has turned testing into a cost-effective tool. However, when developing computer systems for pharmaceuticals manufacturing, testing to meet regulatory requirements adds an additional layer of complexity. Testing Computers Systems for FDA/MHRA Compliance focuses on software module, software integration, hardware, and system acceptance testing. Reflecting the renewed emphasis of the FDA and other global regulatory agencies towards systematic inspections and risk-based validation with an underlying scientific rationale, this guide focuses on current best practices in computer systems testing in the regulatory environment.
David Stokes demonstrates how the principles detailed in the GAMP 4 Guide can be used to define a pragmatic approach to testing. He includes techniques for testing large Internet-based systems for compliance with the stringent requirements of regulations such as 21CFR Part 11, and clarifies the relationship and responsibilities of the system "user" and "supplier". The author also delineates where testing starts in the project lifecycle, who performs what testing, where the lines of responsibility start and end, and the differences in the terminology used in the healthcare and general IT sectors. A checklist of questions to be used when developing System Test Specification(s), and templates for documenting typical system test results, round out the features that make this book a practical guide for all those involved in the development and implementation of IT systems for the pharmaceutical and related healthcare manufacturing industries. Senior managers, team project leaders, project team members, and industry trainees, will all benefit from this clear and practical guide.
Table of Contents
What this Guideline Covers
When this Guideline is Applicable?
Who this Guideline is Intended for?
WHY DO WE TEST?
Because the Regulators Require Us to...
Because the Quality Assurance Department Require Us to...
Because We've Always Done it this Way...
Because it Saves Money!
WHAT TO TEST
Test Rationale and Test Policies
Testing or Verification?
THE TEST STRATEGY
Risk Based Rationale
The Relationship Between Test Specification(s)
Integrating or Omitting the System test Specification(s)
The Role of Factory and Site Acceptance Tests
Roles and Responsibilities
Relationships with Other Lifecycle Phases and Documents (Inputs and Outputs)
THE DEVELOPMENT LIFECYCLE OF A TEST SPECIFICATION
Recommended Phasing; Interfaces Between and the Dependencies of Activities
Milestones in the Process
Inputs to the Development of a Test Specification
Constraints on the Development of a Test Specification
Constraints on the Testing
Conducting the Tests
Outputs from the Testing
RECOMMENDED CONTENT FOR SYSTEM TEST SPECIFICATION(S)
Individual Test Cases
GOOD TESTING PRACTICES
Prepare for Success
Testing in the Life Science Industries is Different
An Overview of the Test Programme
Roles and Responsibilities
Managing a Test Programme
Checking Test Scripts in and out
Recording Test Results
To Sign or Not to Sign
The Use of Test Witnesses
Capturing Test Evidence (Raw Data)
Proceed or Abort? (Test Incident Management)
Categorising Test Incidents
Test Execution Status
Test Data Status
Test Log-On Accounts (User IDs)
SUPPLIER SYSTEM TEST REPORTS/QUALIFICATION
THE USE OF ELECTRONIC TEST MANAGEMENT AND AUTOMATED TEST TOOLS
The Need for Test Tools in the Pharmaceutical Industry
Test Tool Functionality
Electronic Records and Electronic Signature Compliance
The Availability of Suitable Test Tools
Test Script Lifecycle
Flexibility for Non-GxP Use
Project and Compliance Approach
Testing Test Tools
Test Record Integrity
Features to Look Out For
Appendix A - Hardware test specification and testing
Appendix B - Package Configuration Test Specifications and Testing
Appendix C - Software Module Test Specifications and Testing
Appendix D - Software Integration Test Specifications and Testing
Appendix E - System Acceptance Test Specifications and Testing
Appendix F - Risk Based Testing
Appendix G - Traceability Matrices
Appendix H - Test Script Templates
Appendix I - Checklists
Appendix J - References and Acknowledgements