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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 BioTech 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.

Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerised systems used as part of a GMP regulated activities and defines Computer System Validation Elements [2]

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: Specifies required aims of the system. As opposed to specifying nice-to-have aims of the system.
  • Hardware Requirements Specification: Minimum hardware required to support the system.

See also

References

  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.
  2. ^ EUROPEAN COMMISSION (2011-06-30). "EudraLex, The Rules Governing Medicinal Products in the European Union Volume 4, Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 11: Computerised Systems" (PDF). European Commission. Retrieved 2023-03-11. {{cite web}}: line feed character in |title= at position 71 (help)
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