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Method Validation and Verification

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Method Validation and VerificationLauren N. Pearson, DO, MPHLaboratory Director, University of Utah Health Sciences Center Clinical Laboratories AUGUST 2020ObjectivesIdentify the difference between Method Validation and Method verificationDescribe the studies required to document Method performanceInterpret Method performance data and statistical data outcomes2Context and definitionsRegulatory requirementsStudies required for analytical Verification and analytical Validation Outline 3Context and Definitions4Validation versus VerificationValidation Establishing the performance specifications of a new diagnostic tool such as a new test, laboratory developed test or modified methodVerification A one-time process to determine performance characteristics of a test before use in patient testing5Why Evaluate a Method ?

Feb 12, 2018 · Validation versus Verification Validation » Establishing the performance specifications of a new diagnostic tool such as a new test, laboratory developed test or modified method Verification » A one-time process to determine performance characteristics of a test before use in patient testing 5

  Verification, Validation, Verification validation

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