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Computerized system validation

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Computer system validation (CSV) is the documented process of assuring that a computer system does exactly what it is designed to do in a consistent and reproducible manner. 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

[http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf Guidance Compliance Regulatory Information

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