| Description |
1 online resource (132 pages) |
| Contents |
Front Cover; Table of Contents; Author's Preface; 1. Purpose; 2. Scope; 3. Why Do We Test?; 4. What to Test; 5. The Test Strategy; 6. The Development Life Cycle of a Test Specification; 7. Recommended Content for System Test Specification(s); 8. Good Testing Practices; 9. Supplier System Test Reports/Qualification Reports; 10. The Use of Electronic Test Management and Automated Test Tools; 11. Appendix A -- Hardware Test Specification and Testing; 12. Appendix B -- Package Configuration Test Specifications and Testing |
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13. Appendix C -- Software Module Test Specifications and Testing14. Appendix D -- Software Integration Test Specifications and Testing; 15. Appendix E -- System Acceptance Test Specifications and Testing; 16. Appendix F -- Risk-Based Testing; 17. Appendix G -- Traceability Matrices; 18. Appendix H -- Test Script Templates; 19. Appendix I -- Checklists; 20. Appendix J -- References and Acknowledgments; Back Cover |
| Summary |
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 agenc |
| Notes |
Print version record |
| Subject |
Computers -- Testing
|
|
Pharmaceutical technology -- Automation -- Quality control
|
|
Pharmaceutical technology -- Software -- Testing
|
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Computers -- Testing
|
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Pharmaceutical technology -- Automation -- Quality control
|
| Form |
Electronic book
|
| ISBN |
9781135505981 |
|
1135505985 |
|
