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

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reliability

The ability of a system or component to perform its required functions under stated conditions for a specified period of time.

regression analysis and testing

A software verification and validation task to determine the extent of verification and validation analysis and testing that must be repeated when changes are made to any previously examined software ...

predicate rule

Any requirements set forth in the Act (Federal Food, Drug and Cosmetic Act), the PHS Act (Public Health Service Act), or any FDA regulation (GxP: GLP, GMP, GCP, etc.), with the exception of part 11. ...

off-the-shelf software

A generally available software component for which the user can not claim complete software life cycle control.

open system

An environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the 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.

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 ...