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What Is CFR 21 Part 11?

Title 21 -- FOOD AND DRUGS



21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that outlines the US Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures. Here’s the exhaustive guide from the FDA, if you’re into long documents. Each title of the CFR addresses a different regulated area, 21 CFR relates to Pharmaceuticals and Medical Devices and Part 11 addresses electronic records and electronic signatures.

At the most general level, Part 11 is a law that ensures that companies and organizations implement good business practices by defining the criteria under which electronic records and signatures are considered to be accurate, authentic, and equivalent to paper records and handwritten signatures on paper. Part 11 essentially allows an electronic record to take the place of a paper record, and allows any handwritten signature to be replaced by an electronic signature.

What the definitions are…           

  • Electronic Record: "Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system" (21 CFR 11.3(b)(6)).
  • Electronic Signature: "A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature" (21 CFR 11.3(b)(7)).
  • Digital Signature: "An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified" (21 CFR 11.3(b)(5)).
  • Handwritten Signature: "The scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument, such as a pen or stylus, is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark" (21 CFR 11.3(b)(8)).

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