Pharmaceutical Computer Systems Validation
Crc Press Inc (Verlag)
978-1-4200-8894-6 (ISBN)
Key topics in Pharmaceutical Computer Systems Validation, Second Edition include:
GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008
ICH Guidance Q8, Q9, and Q10 expectations
FDA cGMPs for the 21st Century Initiative and associated guidance
PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments
WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
the indirect developments from FDA/EU/Japan regulators and industry
the role of QA department, and internal and external suppliers
the integration of computer systems validation into single overall approach for wider system
practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system
managing outsource partners and handling legacy systems
topical issues uncovered by regulatory authorities including US FDA
Guy Wingate
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
| Erscheint lt. Verlag | 23.2.2010 |
|---|---|
| Zusatzinfo | 320 Illustrations, black and white |
| Verlagsort | Bosa Roca |
| Sprache | englisch |
| Maße | 178 x 254 mm |
| Gewicht | 1519 g |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Laboratoriumsmedizin |
| Studium ► Querschnittsbereiche ► Epidemiologie / Med. Biometrie | |
| Naturwissenschaften ► Biologie | |
| Technik | |
| ISBN-10 | 1-4200-8894-7 / 1420088947 |
| ISBN-13 | 978-1-4200-8894-6 / 9781420088946 |
| Zustand | Neuware |
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