05148oam 2200757I 450 991045927170332120200520144314.00-429-13762-11-282-56102-297866125610231-4200-8895-510.3109/9781420088953 (CKB)2670000000014356(EBL)1186497(OCoLC)843642693(SSID)ssj0000364282(PQKBManifestationID)11262315(PQKBTitleCode)TC0000364282(PQKBWorkID)10394805(PQKB)10050079(MiAaPQ)EBC1186497(MiAaPQ)EBC510086(Au-PeEL)EBL1186497(CaPaEBR)ebr10373300(CaONFJC)MIL256102(OCoLC)680614244(Au-PeEL)EBL510086(OCoLC)609861125(EXLCZ)99267000000001435620180331d2010 uy 0engur|n|---|||||txtccrPharmaceutical computer systems validation quality assurance, risk management and regulatory compliance /edited by Guy Wingate2nd ed.New York :Informa Healthcare,2010.1 online resource (773 p.)Rev. ed. of: Computer systems validation / editor, Guy Wingate. Boca Raton, Fla. : Interpharm/CRC, c2004.1-4200-8894-7 Includes bibliographical references and index.Front Cover; Foreword to the Second Edition; Foreword to the First Edition; Preface; Contributor Biographies; Abbreviations; Contents; Chapter 1. Introduction; Chapter 2. Organization and Management; Chapter 3. Supporting Processes; Chapter 4. Prospective Verification and Validation; Chapter 5. Project Initiation and Compliance Determination; Chapter 6. Requirements Capture and Supplier (Vendor)Selection; Chapter 7. Design and Development; Chapter 8. Coding, Configuration, and Build; Chapter 9. Development Testing; Chapter 10. User Qualification and Authorization to UseChapter 11. Operation and MaintenanceChapter 12. Phaseout and Withdrawal; Chapter 13. Electronic Records and Electronic Signatures; Chapter 14. Regulatory Inspections; Chapter 15. Compliance Strategies; Chapter 16. Capabilities, Measures, and Performance; Chapter 17. Practical Troubleshooting; Chapter 18. Concluding Remarks; Chapter 19. Case Study 1: Computerized Analytical Laboratory Systems; Chapter 20. Case Study 2: Chromatography Data Systems; Chapter 21. Case Study 3: Laboratory Information Management Systems; Chapter 22. Case Study 4: Clinical SystemsChapter 23. Case Study 5: Control and Monitoring InstrumentationChapter 24. Case Study 6: Process Control Systems; Chapter 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records; Chapter 26. Case Study 8: Building Management Systems; Chapter 27. Case Study 9: Engineering Management Systems; Chapter 28. Case Study 10: Desktop Applications Including Spreadsheets; Chapter 29. Case Study 11: Databases; Chapter 30. Case Study 12: Electronic Document Management Systems; Chapter 31. Case Study 13: Enterprise Resource Planning SystemsChapter 32. Case Study 14: Marketing and Supply ApplicationsChapter 33. Case Study 15: IT Infrastructure and Associated Services; Chapter 34. Case Study 16: Internet/Intranet Applications; Chapter 35. Case Study 17: Medical Devices and Their Automated Manufacture; Chapter 36. Case Study 18: Blood Establishment Computer Systems; Chapter 37. Case Study 19: Process Analytical Technology; Chapter 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products; Glossary; Back CoverThoroughly 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 wPharmaceutical industryManagementPharmaceutical industryData processingHealth facilitiesRisk managementRisk managementData processingElectronic books.Pharmaceutical industryManagement.Pharmaceutical industryData processing.Health facilitiesRisk management.Risk managementData processing.615.1068/4615.10684Wingate Guy1048627MiAaPQMiAaPQMiAaPQBOOK9910459271703321Pharmaceutical computer systems validation2477039UNINA