1st Edition

Testing Computers Systems for FDA/MHRA Compliance

By David Stokes Copyright 2004
    136 Pages 7 B/W Illustrations
    by CRC Press

    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.

    PURPOSE

    SCOPE
    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
    GxP Priority
    Software/Hardware Category
    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
    Document Evolution
    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)
    Overview
    General section
    Individual Test Cases

    GOOD TESTING PRACTICES
    Prepare for Success
    Common Problems
    Testing in the Life Science Industries is Different
    Prerequisite Training
    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
    Impact Assessment
    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
    Incident 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

    Biography

    David Stokes