📋 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

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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. Get in touch with our regulatory experts.