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 requirements[edit]

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.

The formal definition of validation from the US Food and Drug Administration (FDA) is:

“Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” (Source: FDA Guidelines on General Principles of Process Validation, 1987) [Phil Latham, Director, MNL Limited, www.mnl-limited.com 5/7/06]

See also[edit]

See also: www.mnl-limited.com/services.htm for a full explanation of CSV. [Phil Latham, Director, MNL Limited, www.mnl-limited.com 5/7/06]
IT Pharma Validation Organizations: www.it-validation.eu [1] or www.it-validation.org [2]
GAMP Guide: www.ispe.org [3]