What Does Title 21 CFR Part 11 Deal With?


Quick Answer

Title 21 CFR Part 11 deals with whether electronic records and electronic signatures are reliable and equivalent to paper records, according to the U.S. Food and Drug Administration. Part 11 sets out the verification requirements for valid electronic signatures.

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Full Answer

Electronic signatures do not include paper records that are sent electronically. Part 11 states that electronic signatures verified through the methods described in Part 11 are acceptable in lieu of paper records, unless paper records are specifically requested, as 21 CFR 11.1(d) explains. Part 11 also sets out specific controls for open and closed systems. Section 11.50 gives informational requirements for electronic signatures, including the printed name of the signer, date and time, and the meaning associated with the signature.

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