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Validation: In the pharmaceutical, medical device, food, and clinical trials industries, validation is the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices (GMP), the Food and Drug Administration (FDA), and other regulatory agencies. Validation is a more stringent, regulated version of Commissioning.
Examples: Equipment validation, Facilities validation, HVAC system validation, Cleaning validation, Process validation, Analytical method validation, Computer system validation, Design qualification (DQ), Component qualification (CQ), Installation qualification (IQ), Operational qualification (OQ), Performance qualification (PQ).
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