21CFR Part 11 Insights

What is 21CFR Part 11?

21 CFR Part 11 is a regulation from the United States Food and Drug Administration (FDA) that sets forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. It applies to pharmaceutical, biotechnology, medical device, and other FDA-regulated industries. Compliance involves implementing controls and procedures to ensure data integrity, audit trails, system validation, and security, ensuring that electronic records can be trusted for regulatory purposes.

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What other technologies are related to 21CFR Part 11?

21CFR Part 11 Complementary Technologies

GAMP5

GAMP 5 (Good Automated Manufacturing Practice) provides guidance for the validation of computerized systems in regulated industries, which is essential for 21 CFR Part 11 compliance. It is strongly complementary because it helps organizations implement systems that meet Part 11 requirements.

mentioned alongside 21CFR Part 11 in 7% (129) of relevant job posts

GAMP

GAMP (Good Automated Manufacturing Practice) refers to a set of principles and procedures for computer system validation in the pharmaceutical and related industries. It's complementary as it guides the implementation of systems that comply with 21 CFR Part 11.

mentioned alongside 21CFR Part 11 in 3% (77) of relevant job posts

GAMP 5

GAMP 5 (Good Automated Manufacturing Practice) provides guidance for the validation of computerized systems in regulated industries, which is essential for 21 CFR Part 11 compliance. It is strongly complementary because it helps organizations implement systems that meet Part 11 requirements.

mentioned alongside 21CFR Part 11 in 2% (54) of relevant job posts