From this book, you will learn a systematic, step-by-step approach for validating configurable off-the-shelf software that generates data or controls information about products and processes subject to regulations. You will also get access to templates the authors have used as training tools for more than 1,000 companies and components of more than 300 validation projects. These tools and knowledge will assist you in establishing a compliant, timely, and successful program.
Table of Contents:
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- Understanding the Process
- The Groundwork
- The Plan and Installation
- Functional Specifications and Hazard Analysis
- Training, User Testing, and System Release
- Assessing the System and Remaining Vigilant
- Writing Guidelines
About the Authors
David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Date Protection Regulation (GDPR), software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects.
Janet Gough trains staff in medical and technical writing within the regulated environment. She helps prepare documentation and assists companies in designing and implementing document management systems for compliance with 21 CFR Part 11 and the predicate rules. She has taught English in university graduate and undergraduate programs and served as a director of technical communications for a biotechnical company. She has written over 35 journal articles and authored and co-authored 15 industry books.