Method Validation and Verification
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 ? Document initial performance: Reference when troubleshooting problems Quality assurance -to ensure results Helpful for clinical consultations Meet regulatory requirements 6Laboratory Regulations General and open to some interpretation Direct what must be done, not how it is Test Categorization Determined during FDA pre-market approval Waived testing Approved for home and point-of-care use Low risk of patient mismanagement if performed incorrectly Non-waived testing Moderate Complexity High Complexity LDTs Modified Tests 8 Accessed February 12, Requirements9Waiv
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
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