Cantitate/Preț
Produs
Total produse
Vezi coșul
Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance de Guy Wingate

Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance: Drugs and the Pharmaceutical Sciences

Editat de Guy Wingate
en Limba Engleză Paperback – 14 oct 2024
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 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
Citește tot Restrânge

Din seria Drugs and the Pharmaceutical Sciences

Preț: 43249 lei

Puncte Express: 649
Paperback (2) de la 43249 lei
Hardback 152906 lei

Carte disponibilă

Livrare economică 17-31 august
Livrare express 31 iulie-06 august pentru 3503 lei

Livrare prin curier în România Termenul estimat este afișat lângă disponibilitate.
Transport gratuit pentru acest produs Plată online sau ramburs, în funcție de opțiunile comenzii.
Retur gratuit în 14 zile Comandă securizată și suport în română.
 Adaugă în coș

Wish list
Gift list
Am citit!
Adaugă în listă

Specificații

ISBN-13: 9781032917511
ISBN-10: 1032917512
Pagini: 798
Ilustrații: 320
Dimensiuni: 178 x 254 x 46 mm
Greutate: 0.45 kg
Ediția:2
Editura: CRC Press
Colecția CRC Press
Seria Drugs and the Pharmaceutical Sciences

Locul publicării:Boca Raton, United States

Public țintă

Academic and Professional Practice & Development

Cuprins

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

Descriere

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

Notă biografică

Guy Wingate, Ph.D., was Vice‑President of Compliance and before that Director of Global Computer Validation at GlaxoSmithKline until his recent retirement. A well‑known speaker on computer validation, he has over 30 years of experience in the pharmaceutical industry. He has been a visiting lecturer at the University of Manchester’s M.Sc. in Pharmaceutical Engineering Advanced Training program and the Dublin Institute of Technology’s accredited M.Sc. in Validation Science program. He is an active member of the ISPE and served as Chair of the GAMP® Council for 10 years, which is responsible for the internationally recognized suite of GAMP® Guides on computer compliance. Guy led the teams who produced the original GAMP®5 Guide: A Risk Based Approach to Compliant GxP Computerized Systems and the GAMP® Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures. His extensive list of published work also includes the books Validating Automated Manufacturing and Laroratoty Applications, Validating Corporate Computer Systems and previous editions of this book, Pharmaceutical Computer Systems Validation.

Recenzii

This book’s strong emphasis on governance, management oversight, and maintaining control throughout the operational life cycle [of computer systems used in the pharmaceutical industry] is both timely and necessary.
A key challenge for today’s organizations today is the shift from validating systems at a point in time to assuring them continuously throughout their life. Modern development and delivery approaches, such as Agile and DevOps, can support this goal, but only when the supporting controls are designed deliberately and applied consistently. Clear intent of requirements, risk‐based decision‐making, appropriate testing strategies for high‐risk functions, robust release and configuration management, and effective supplier oversight remain essential. Several chapters in the book address these realities directly, focusing on the areas where compliance most often degrades: operation, maintenance, and change.
At the same time, the regulatory and compliance landscape continues to evolve. There is sustained global focus on data governance and data integrity, including expectations for effective investigation, remediation, and prevention of recurrence. Cybersecurity, data availability, and business continuity are receiving increased attention, reflecting their direct impact on product quality and patient safety. Regulators also increasingly expect organizations to understand, control, and justify the use of emerging technologies, particularly where these technologies influence GxP decisions, regulated records, or regulatory submissions.
What is particularly welcome about this book is its practical orientation. While regulations and guidance are widely available, many organizations struggle to translate high‐level principles into consistent execution across diverse system types and life cycle stages. This work helps to bridge that gap. Through its structured approach and breadth of examples, from laboratory and manufacturing systems to enterprise platforms, infrastructure, cloud services, and data‐intensive digital architectures, it provides practitioners with a coherent framework grounded in real operational experience.
I would encourage readers to approach this book not simply as a compliance manual, but as a guide to building organizational capability. Capability means being able to explain, with confidence, how and why controls are proportionate to risk; demonstrating that systems are fit for their intended use; evidencing that data remain complete, consistent, and trustworthy throughout the data life cycle; and showing that the organization learns through effective management review, meaningful metrics, and a culture that treats issues as opportunities for improvement rather than occasions for blame.
In an era of increasing digital dependence, this capability is not optional. It is fundamental to protecting patients, safeguarding product quality, and maintaining trust in the organizations responsible for both. I commend this book to practitioners, managers, and auditors alike, and I hope it serves as a practical companion in building the right environment, technical, procedural, and cultural, for robust computer compliance and data integrity.
Tracy Moore
Former Expert GMP Inspector, UK Medicines & Healthcare products Regulatory Agency (MHRA)