ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Validation, Retrospective

(FDA) Validation of a process for a product already in distribution based upon accumulated production, testing and control data.

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

Validation, Retrospective

Retrospective validation can also be useful to augment initial premarket prospective validation for new products or changed processes. Test data is useful only if the methods and results are adequately specific. Whenever test data are used to demonstrate conformance to specifications, it is important that the test methodology be qualified to assure that the test results are objective and accurate.

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

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