Digital signature

Part 11 treats a digital signature as one kind of electronic signature. Most eQMS approvals use a user ID and password, which are electronic signatures but not digital signatures; digital signatures matter more for open systems, where Part 11 asks for extra controls.

(5) Digital signature means 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