Practical Guide to 21 CFR Part 11
Your Essential Handbook for Navigating 21 CFR Part 11
"An invaluable resource for anyone working with computerised systems in pharma."
Conor
Quality Assurance
Available on Amazon United Kingdom
This comprehensive guide offers a clear, practical approach to understanding and implementing the key requirements of 21 CFR Part 11. Drawing on the author's extensive experience, this book goes beyond regulatory theory, providing actionable insights and real-world examples to help you achieve and maintain compliance.
What You will Learn
Electronic Records
Detailed guidance on controls for closed and open systems, including validation, audit trails, and record protection.
Electronic Signatures
Understanding the requirements for electronic and digital signatures, with practical steps for implementation.
System Documentation
Best practices for managing system documentation, user access, and backups, with an emphasis on maintaining data integrity.
User Requirement Specifications
Examples of essential system requirements to ensure compliance with Part 11.
Why You Should Read This Book
Comprehensive Understanding
Equip yourself with a deep understanding of 21 CFR Part 11 and how it applies to your work.
Real-World Examples
Benefit from step-by-step procedures, checklists, and examples you can directly apply.
Enhanced Skills
Learn practical approaches to implementing regulatory requirements and managing electronic records.
Compliance Confidence
Navigate the complexities of 21 CFR Part 11 with confidence and ensure FDA compliance.
Who Should Read This Book
- Validation Engineers seeking to enhance their knowledge and skills
- Automation Engineers working with regulated systems
- Quality Assurance Professionals responsible for compliance
- Newcomers to the field looking to build a strong foundation
About the Author
Niall O'Rourke
Computerised System Validation (CSV) Engineer | Software Developer | Author
CSV Engineer in Bio-Pharma, full-stack developer, and author of "A Practical Guide to 21 CFR Part 11." I build web apps like this one and share practical insights for engineers. Follow me below on social media for interesting, hands-on content!
Ready to Master 21 CFR Part 11?
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Available on Amazon United Kingdom