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.
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