Blossary – 21 CFR Part 11 -- Electronic Records and Electronic Signatures

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21 CFR Part 11 -- Electronic Records and Electronic Signatures

Terms used in the Food and Drug Administration's (FDA’s) guidance on principles and procedures for creating, modifying, maintaining, archiving, retrieving, and transmitting electronic records and electronic signatures under the requirements of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures. Many life science businesses (pharmaceutical and medical devices companies) are subject to the rule and must comply with the regulation.

Category: Health

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Created by: nicktruth

Number of Blossarys: 1

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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 ...

computer systems validation

Confirmation by examination and provision of objective evidence that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled.

closed system

An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

biometrics

A method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable actions where those features and/or actions are both unique to that ...