Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management a

Description: Pharmaceutical Computer Systems Validation by Guy Wingate Pharmaceutical Computer Systems Validation FORMAT Hardcover LANGUAGE English CONDITION Brand New Publisher Description 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.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 2008ICH Guidance Q8, Q9, and Q10 expectationsFDA cGMPs for the 21st Century Initiative and associated guidancePIC/S Guidance on Good Practice for Computerized Systems in GxP EnvironmentsWK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipmentthe indirect developments from FDA/EU/Japan regulators and industrythe role of QA department, and internal and external suppliersthe integration of computer systems validation into single overall approach for wider systempractical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer systemmanaging outsource partners and handling legacy systemstopical issues uncovered by regulatory authorities including US FDA Author Biography Guy Wingate Table of Contents 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 Details ISBN1420088947 Short Title PHARMACEUTICAL COMPUTER SYSTEM Language English Edition 2nd ISBN-10 1420088947 ISBN-13 9781420088946 Media Book Format Hardcover Subtitle Quality Assurance, Risk Management and Regulatory Compliance Country of Publication United States Edited by Guy Wingate DOI 10.1604/9781420088946 UK Release Date 2010-02-23 Imprint CRC Press Inc Place of Publication Bosa Roca AU Release Date 2010-02-23 NZ Release Date 2010-02-23 US Release Date 2010-02-23 Author Guy Wingate Pages 798 Publisher Taylor & Francis Inc Edition Description 2nd edition Year 2010 Publication Date 2010-02-23 DEWEY 615.1068/4 Illustrations 320 Illustrations, black and white Audience Professional & Vocational Alternative 9781032917511 We've got this At The Nile, if you're looking for it, we've got it. With fast shipping, low prices, friendly service and well over a million items - you're bound to find what you want, at a price you'll love! TheNile_Item_ID:134472542;

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