What is Title 21 CFR Part 11 (CFR Part 11)?

Title 21 CFR Part 11 Definition

FDA Title 21 CFR Part 11 regulates electronic records and electronic signatures (ERES) for life science companies. Part 11 establishes when electronic signatures are considered to be trustworthy, reliable, and/or the equivalent to paper records.

FAQs

What is the main purpose of 21 CFR Part 11?

CFR Part 11 content is being added. Stay tuned.

What is FDA 21 CFR Part 11 compliance?

CFR Part 11 content is being added. Stay tuned.

What does Title 21 of CFR describe?

CFR Part 11 content is being added. Stay tuned.

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