ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Process by which adjustments to, and regulation of, individual systems are demonstrated as within the required tolerances, system components are demonstrated as delivering the required capacity or duty, the functions of the system are demonstrated as delivering the required capacity of duty, the functions of the system are demonstrated to be as specified and appropriate.

Publication Source: ISPE Baseline® Guide, Vol. 5: Commissioning and Qualification

Publication Date: 2001


(IEEE) The process of exercising or evaluating a system or system component by manual or automated means to verify that it satisfies specified requirements or to identify differences between expected and actual results.

Publication Source: GAMP® Good Practice Guide: IT Infrastructure Control and Compliance

Publication Date: 2005


The process of analyzing a software item to detect the differences between existing and required conditions, i.e. bugs, and to evaluate the features of the software items. (also see: Dynamic Analysis, Static Analysis, Software Engineering)

Publication Source: FDA Glossary of Computerized System and Software Development Technology

See also: Dynamic Analysis Software Engineering Static Analysis

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