Pharmaceutical Computer Systems Validation : Quality Assurance, Risk Management and Regulatory Compliance.

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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 fo...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Wingate, Guy
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken : CRC Press, 2010.
Edición:2nd ed.
Temas:
Pharmaceutical industry > Management.
Pharmaceutical industry > Data processing.
Health facilities > Risk management.
Risk management > Data processing.
Industrie pharmaceutique > Gestion.
Industrie pharmaceutique > Informatique.
Équipements sanitaires > Gestion du risque.
Gestion du risque > Informatique.
MEDICAL > Pharmacology.
Health facilities > Risk management
Pharmaceutical industry > Data processing
Pharmaceutical industry > Management
Risk management > Data processing
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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 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
  • Glossary
  • Back Cover.

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