Jump to content

Computerized system validation

From Wikipedia, the free encyclopedia
This is an old revision of this page, as edited by Wikiguy91311 (talk | contribs) at 04:21, 10 September 2021 (Edited first paragraph to be more precise and accurate and added citation. Strongly suggest changing article name to "Computer System Validation" as this is what it is commonly referred to; I will suggest that in Talk.). The present address (URL) is a permanent link to this revision, which may differ significantly from the current revision.

Computer system validation (CSV) is the process of testing/validating/qualifying a regulated (E.g., FDA 21CFR11[1]) computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper records. The validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules

System requirement

Documented system requirements are required for CSV as they clearly stipulate the intended use of a computer system application. System requirements are gathered and documented in the system definition phase. System definition artifacts that reflect these requirements can include, but are not limited to, the following:

  • User Requirements Specification: Details each feature of the system.
  • Hardware Requirements Specification: Minimum hardware required to support the system.

See also

Guidance Compliance Regulatory Information

  1. ^ Commissioner, Office of the (2020-06-11). "Part 11, Electronic Records; Electronic Signatures - Scope and Application". U.S. Food and Drug Administration. Retrieved 2021-09-10.
Retrieved from "https://en.wikipedia.org/w/index.php?title=Computerized_system_validation&oldid=1043447354"