Friday, September 22

Pharmaceutical computer systems validation quality assurance, risk management and regulatory compliance 2nd Edition Pdf Free

Pharmaceutical computer systems validation quality assurance: This book is written by Guy Wingate which you can download freely in pdf format. This is the second edition of this book and much has changed in the world of IT compliance since it was first published five years ago. The combination of economic pressures and the desire to maximize value for money is driving a new way of thinking. The bureaucratic practices often associated with validation have been widely questioned rather than accepted through rumors that they are driven by regulations. Professionals feel empowered to justify more efficient and effective ways of working. The role of risk management throughout the life cycle of an IT system is understood not only for the benefit of patient/consumer safety but also in terms of profitability. The next step is to make the largely subjective risk assessments more scientific by using relevant data. Combine this thinking with a focus on proving that an IT system is fit for purpose through process capability rather than compliance cross-checking, and it’s fair to say a new paradigm has emerged.
The structure of this second edition remains the same, with the first part providing chapters that discuss the new paradigm, organization, and management of compliance activities, and lifecycle requirements going through the development, verification, operation, and decommissioning of computer systems. In addition, there are chapters covering the latest developments in electronic registration and signature requirements, new practical guidance on risk-based decisions, handling regulatory inspections, and improving organizational capabilities to deliver highly efficient and effective compliance through six sigma. and lean manufacturing philosophies. Throughout the book, I have included actual observations recently made by the FDA on the various topics discussed.


Book Name Pharmaceutical computer systems validation quality assurance
Author of Book Guy Wingate
Edition 2nd
Language English
Format PDF
Category Pharmaceuticals Books


Overview of Pharmaceutical computer systems validation Pdf Free

According to Guy Wingate, the second part of the book provides a series of case studies that show how the principles explained above can be put into practice. The real world is seldom as simple and straightforward as we might hope, and I have been very interested in putting together a group of case studies to share practical solutions to the many and varied challenges practitioners can face. The case studies cover most types of computer systems in use today in R&D, manufacturing, and commercial supply organizations. The original case studies have undergone significant revision and new case studies have been added to keep the information presented current and relevant. I have encouraged contributors to include relevant checklists on key aspects of their case studies to complement the more generic guidance provided in the first part of the book.
Once again, I am greatly indebted to the large number of contributors, each of whom was invited to participate on the basis of his recognized expertise (see Biographies). In addition, I would also like to thank friends and colleagues who have provided invaluable discussions and explorations of IT compliance principles and practices over the years. In particular, I would like to thank Sam Brooks (Novartis Consumer Healthcare), Ellis Daw (GlaxoSmithKline), Paul D’Eramo (Johnson & Johnson), Howard Garston-Smith (Gartson Smith Associates), Jerry Hare (Independent Consultant), Niels Holger Hansen (Novo Nordisk), Paige Kane (Wyeth Biotech), Scott Lewis (Eli Lilly), Takayoshi Matsumura (Eisai), Karl-Heinz Menges (Darmstadt German GMP Inspectorate), Gordon Richman (EduQuest), Peter Roberston (AstraZeneca), David Selby (Selby-Hope) and Sion Wyn (Conformity).

Key features

  • 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 guideline expectations Q8, Q9, and Q10
  • FDA cGMP for the 21st Century Initiative and associated guidance
  • PIC/S Guide on Good Practices for Computerized Systems in GxP Environments
  • WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical
  • Manufacturing Equipment and Systems
  • Indirect developments from FDA/EU/Japan regulators and industry
  • The role of the quality control department and internal and external suppliers
  • Integrating the validation of IT systems into a single general approach for a larger system
  • Practical guidance on handling common high, medium, and low-risk issues that can occur during the life cycle of an IT system
  • Manage outsourced partners and manage legacy systems
  • Hot topics discovered by regulatory authorities, including the US FDA.

Topics of this Edition

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 Use
Chapter 11. Operation and Maintenance
Chapter 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 Systems
Chapter 23. Case Study 5: Control and Monitoring Instrumentation
Chapter 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 Systems
Chapter 32. Case Study 14: Marketing and Supply Applications
Chapter 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



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