ISPE Glossary of Pharmaceutical and Biotechnology Terminology
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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