Validation of Chromatography Data Systems
eBook - PDF

Validation of Chromatography Data Systems

Ensuring Data Integrity, Meeting Business and Regulatory Requirements

Robert McDowall

  1. 733 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Validation of Chromatography Data Systems

Ensuring Data Integrity, Meeting Business and Regulatory Requirements

Robert McDowall

Book details
Table of contents
Citations

About This Book

Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate.

The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer's book shelf.

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Information

Publisher
Royal Society of Chemistry
Year
2016
ISBN
9781782624073
Edition
2
Topic
Sciences physiques
Subtopic
Chimie analytique

Table of contents

  1. Cover
  2. Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements 2nd Edition
  3. Preface to the First Edition
  4. Preface to the Second Edition
  5. Biography
  6. Acknowledgements
  7. Contents
  8. Chapter 1 - How to Use this Book
  9. Chapter 2 - What is a CDS The Past, Present and Future
  10. Chapter 3 - Laboratory Informatics and the Role of a CDS
  11. Chapter 4 - Applicable GXP Regulations and Guidance for CSV
  12. Chapter 5 - Concepts of Computer Validation
  13. Chapter 6 - Understanding Software Categories and System Life Cycles
  14. Chapter 7 - Ensuring Data Integrity for Chromatography Data Systems
  15. Chapter 8 - CDS Validation: Managing System Risk
  16. Chapter 9 - Working Electronically and Using Electronic Signatures
  17. Chapter 10 - Writing the User and System Requirements
  18. Chapter 11 - Controlling the Validation
  19. Chapter 12 - System Selection
  20. Chapter 13 - Assessing the CDS Supplier
  21. Chapter 14 - Negotiating the Contract and Purchasing the System
  22. Chapter 15 - Planning the Installation of the System
  23. Chapter 16 - CSV Risk Management Requirements Level Assessment
  24. Chapter 17 - Importance of the Traceability Matrix
  25. Chapter 18 - Writing Configuration Specifications
  26. Chapter 19 - Writing the Technical Specification
  27. Chapter 20 - Installing and Integrating System Components
  28. Chapter 21 - Designing the User Acceptance Test Suite
  29. Chapter 22 - Writing Test Scripts and Test Cases
  30. Chapter 23 - Executing Test Scripts and Reporting the Results
  31. Chapter 24 - User Training and System Documentation
  32. Chapter 25 - IT Support for a CDS
  33. Chapter 26 - System Description
  34. Chapter 27 - Defining Electronic Records and Raw Data for a CDS
  35. Chapter 28 - Writing the Validation Summary Report
  36. Chapter 29 - Integration in a Regulated Environment
  37. Chapter 30 - User Account Management
  38. Chapter 31 - Incident and Problem Management
  39. Chapter 32 - Change Control and Configuration Management
  40. Chapter 33 - Periodic Review of the CDS
  41. Chapter 34 - CDS Records Retention
  42. Chapter 35 - CDS System Retirement
  43. Chapter 36 - CDS Data Migration
  44. Chapter 37 - Retrospective Validation
  45. Glossary and Abbreviations
  46. Subject Index