CFR Part 11

CFR Part 11 refers to the electronic records and electronic signatures regulations set forth by the US Food and Drug Administration (FDA) under Title 21 of the Code of Federal Regulations (CFR).

The regulation was issued in 1997 to establish criteria for the use of electronic records and signatures in place of traditional paper records and handwritten signatures for certain FDA-regulated activities. The goal of the regulation is to ensure the reliability, authenticity, integrity, and confidentiality of electronic records and signatures.

CFR Part 11 applies to FDA-regulated industries such as pharmaceutical, biotech, medical device, and food manufacturing companies. The regulation requires these companies to maintain electronic records and signatures that meet specific requirements for their accuracy, accessibility, security, and accountability.

In summary, CFR Part 11 outlines the requirements that FDA-regulated industries must follow to ensure the trustworthiness and reliability of electronic records and signatures used in their operations.

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