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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. 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, Director, MNL Limited, www.mnl-limited.com 5/7/06 ) 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「computerized system validation」の詳細全文を読む スポンサード リンク
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