What Is Part 11 Compliance?

📋 What Is Part 11 Compliance?

Title 21, Part 11 of the Code of Federal Regulations, also known as 21 CFR Part 11, is essential for medical device and biotech companies managing electronic records. Proxima's Director of Regulatory Affairs and Quality Assurance, Ellie Reynolds, breaks down the fundamentals of Part 11 compliance and explains how it ensures electronic records and signatures are trustworthy, reliable, and legally equivalent to paper documentation.

Key Topics Covered:

✅ What is 21 CFR Part 11?
✅ Who needs to comply with Part 11?
✅ How Part 11 ensures data integrity
✅ Navigating compliance with expert guidance

Whether you're transitioning to electronic record keeping or ensuring your current systems meet regulatory standards, this video provides the essential knowledge you need.

At Proxima Clinical Research, we provide comprehensive regulatory support, including guidance, risk assessments, and validation strategies to ensure your electronic systems meet Part 11 standards.


Want to learn more? Get briefed with our other resources related to this topic!
🔗 21 CFR Part 11 Guide:
https://www.proximacro.com/glossary/2...

🔗 Code of Federal Regulations (CFR):
https://www.proximacro.com/glossary/c...

🎥 Paper Based vs. Electronic QMS:
https://www.proximacro.com/videos/pap...


About Proxima Clinical Research:
Proxima is a CRO that works with innovative medical devices, drugs, and diagnostics. We support MedTech and Biotech companies across all phases of development with regulatory, clinical, and quality support.

Website: https://proximacro.com/
Twitter: @ProximaCRO
LinkedIn:   / proxima-clinical-research  

Business email: [email protected]

#clinicaltrials #medicaldevices #biotech

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Produced by:
Julian Lara, Content Marketing Producer (video, editing)
Brandon Clements, Content Marketing Manager (director)