FDA Compliance Reference from C.H.I.P.S.

Testing Computers Systems for FDA/MHRA Compliance

by David Stokes

  • Demonstrates the value of a systematic approach to computer systems testing
  • Presents a practical method for determining the degree of testing necessary for any given system
  • Provides a detailed guide to computer systems test specifications and details how to produce these in the most cost effective manner possible
  • Discusses the role of computer system testing in the full validation lifecycle and where the tests sit in relation to the overall project
  • Supplies guidance on the use of automated test tools in a compliant environment and covers compliant use of Internet tools

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.

It demonstrates how the principles detailed in the GAMP 4 Guide can be used to define a pragmatic approach to testing. It also 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 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.


  1. Purpose

  2. Scope
    • What this Guideline Covers
    • When this Guideline is Applicable?
    • Who this Guideline is Intended for?

  3. 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!

  4. What to Test
    • GxP Priority
    • Software/Hardware Category
    • Test Rationale and Test Policies
    • Testing or Verification?

  5. 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)

  6. 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

  7. Recommended Content for System Test Specification(s)
    • Overview
    • General section
    • Individual Test Cases

  8. 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)

  9. Supplier System Test Reports/Qualification

  10. 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

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Testing Computers Systems
for FDA/MHRA Compliance

by David Stokes
136 pages $198.95 + shipping

Texas residents please add 6.75 % sales tax

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