Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively review
Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively review
Foreword to the Second Edition Foreword to the First Edition Preface Contributor Biographies Abbreviations Contributors 1. Introduction 2. Organization and Management 3. Supporting Processes 4. Prospective Verification and Validation 5. Project Initiation and Compliance Determination 6. Requirements Capture and Supplier (Vendor) Selection 7. Design and Development 8. Coding Configuration and Build 9. Development Testing 10. User Qualification and Authorization to Use 11. Operation and Maintenance 12. Phaseout and Withdrawal 13. Electronic Records and Electronic Signatures 14. Regulatory Inspections 15. Compliance Strategies 16. Capabilities Measures and Performance 17. Practical Troubleshooting 18. Concluding Remarks 19. Case Study 1: Computerized Analytical Laboratory Systems 20. Case Study 2: Chromatography Data Systems 21. Case Study 3: Laboratory Information Management Systems 22. Case Study 4: Clinical Systems 23. Case Study 5: Control and Monitoring Instrumentation 24. Case Study 6: Process Control Systems 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records 26. Case Study 8: Building Management Systems 27. Case Study 9: Engineering Management Systems 28. Case Study 10: Desktop Applications Including Spreadsheets 29. Case Study 11: Databases 30. Case Study 12: Electronic Document Management Systems 31. Case Study 13: Enterprise Resource Planning Systems 32. Case Study 14: Marketing and Supply Applications 33. Case Study 15: IT Infrastructure and Associated Services 34. Case Study 16: Internet/Intranet Applications 35. Case Study 17: Medical Devices and Their Automated Manufacture 36. Case Study 18: Blood Establishment Computer Systems 37. Case Study 19: Process Analytical Technology 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products Glossary Index
Foreword to the Second Edition Foreword to the First Edition Preface Contributor Biographies Abbreviations Contributors 1. Introduction 2. Organization and Management 3. Supporting Processes 4. Prospective Verification and Validation 5. Project Initiation and Compliance Determination 6. Requirements Capture and Supplier (Vendor) Selection 7. Design and Development 8. Coding Configuration and Build 9. Development Testing 10. User Qualification and Authorization to Use 11. Operation and Maintenance 12. Phaseout and Withdrawal 13. Electronic Records and Electronic Signatures 14. Regulatory Inspections 15. Compliance Strategies 16. Capabilities Measures and Performance 17. Practical Troubleshooting 18. Concluding Remarks 19. Case Study 1: Computerized Analytical Laboratory Systems 20. Case Study 2: Chromatography Data Systems 21. Case Study 3: Laboratory Information Management Systems 22. Case Study 4: Clinical Systems 23. Case Study 5: Control and Monitoring Instrumentation 24. Case Study 6: Process Control Systems 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records 26. Case Study 8: Building Management Systems 27. Case Study 9: Engineering Management Systems 28. Case Study 10: Desktop Applications Including Spreadsheets 29. Case Study 11: Databases 30. Case Study 12: Electronic Document Management Systems 31. Case Study 13: Enterprise Resource Planning Systems 32. Case Study 14: Marketing and Supply Applications 33. Case Study 15: IT Infrastructure and Associated Services 34. Case Study 16: Internet/Intranet Applications 35. Case Study 17: Medical Devices and Their Automated Manufacture 36. Case Study 18: Blood Establishment Computer Systems 37. Case Study 19: Process Analytical Technology 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products Glossary Index
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