Computer Validation – A Common Sense Guide
This book was designed to share practical ideas that have been shown to work well in a variety of computer validation projects and global regulatory environments. These practices are not the only way to perform computer validation, but they are one way that experience has shown to be workable and inspected with positive results.
In chapter appendices there are 29 full scale examples of validation document sets, policies, and SOPs from real projects to illustrate the concepts discussed. In Unit 1, an extensive glossary of 80 validation-related terms provides the reader with quick access to definitions that are understandable by non-IT professionals.
To support focused and distance learning, this book is available as PDF downloads in specific training Units. Dr. Stokes has used these Units herself as pre-seminar reading assignments for participants and also for Case Study exercises and Round Table discussion topics. They provide a flexible training program for all levels of expertise in FDA regulated industries where computer use is subject to Good Practices (Clinical, Manufacturing, Laboratory, Part 11).
INDEX of Book Training Units:
|Book Training Content|
|1||Glossary of Computer Validation Terms and Definitions
Chapter 1 Common Regulatory Compliance Themes, Appendix 1.1
|2||Chapter 2 Management’s role in Computer Validation
Chapter 3 User Team’s role in Computer Validation, Appendix 3.1
|3||Chapter 4 The Auditable Computer Validation Package, Appendix 4.1 and 4.2|
|4||Chapter 5 Auditable Formal Testing Practices, Appendix 5.1-5.6|
|5||Chapter 6 The IT Infrastructure Role in Validation, Appendix 6.1-6.7|
|6||Chapter 7 The Software Supplier’s Role in Computer Validation, Appendix 7.1-7.4|
|7||Chapter 8 Quality Assurance and Quality Control Roles, Appendix 8.1-8.3|
|8||Chapter 9 The Archivist Role for Electronic Archives, Appendix 9.1
Chapter 10 The Corporate Role for Electronic Records Quality, Appendix 10.1-10.4
Each Training Unit listed above (1 – 8) can be purchased below for $20 and downloaded as a pdf file.
All 8 Training Units can be purchased below for $80 and downloaded in one zip file.
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