Computerized system validation

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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.

[edit] System Requirements

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) [Phil Latham 5/7/06]