Pharmaceutical Computer Systems Validation

Quality Assurance, Risk Management and Regulatory Compliance
Herausgeber: Wingate, Guy

• Gebundenes Buch

Produktbeschreibung

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 reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

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Produktdetails

• Verlag: CRC Press
• 2. Auflage
• Seitenzahl: 798
• Erscheinungstermin: 23. Februar 2010
• Englisch
• Abmessung: 260mm x 183mm x 47mm
• Gewicht: 1669g
• ISBN-13: 9781420088946
• ISBN-10: 1420088947
• Artikelnr.: 23809160

Autorenporträt

Guy Wingate

Inhaltsangabe

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