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Computerized system validation

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Computerized system validation (CSV) (usually referred to as "Computer Systems Validation") 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. This is widely used in the Pharmaceutical, Life Sciences and BioTek industries and is a cousin of Software Testing but with a more formal and documented approach. 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.
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