ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Revalidation

Validation of a previously validated system that has been changed or modified. Revalidation can be performed as the result of a change to the system, or a time based assessment.

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

Publication Date: 2001

Revalidation

Extent of validation necessary to assure that changes made to the equipment, utilities, systems and process do not adversely affect the finished product. Implemented changes should be tracked and evaluated through a thorough, dynamic, change control program.

Publication Source: ISPE Baseline® Guide, Vol. 2: Oral Solid Dosage Forms (First Edition)
Publication Date: 1998

Revalidation

Relative to software changes, revalidation means validating the change itself, assessing the nature of the change to determine potential ripple effects, and performing the necessary regression testing.

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

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