Who needs to follow 21 CFR part 11 compliance?
Anyone conducting a clinical trial that uses electronic records in place of paper records, including electronic signatures that are intended to be the equivalent of handwritten signatures.
Part 11.3 Definitions
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.
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.
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.
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