Computerized System Validation (CSV) is the documented process of assuring that a computerized system does exactly what it is designed to do in a consistent and reproducible manner.

System Requirements

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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: What the system needs to do for its user(s)
• Functional Requirements Specification: How each feature of the system functions
• Design Requirements Specification: How each feature of the system is built
• 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) Latham 5/7/06

See also

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• Software testing
• Software engineering
• List of software engineering topics
• Quality Assurance

See also: http://www.mnl-limited.com/services.htm for a full explanation of CSV. Latham 5/7/06