Transcription of Method Validation and Verification
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Method Validation and Verification
Method Validation and VerificationLauren N. Pearson, DO, MPHL aboratory Director, University of Utah Health Sciences Center Clinical Laboratories AUGUST 2020 ObjectivesIdentify the difference between Method Validation and Method verificationDescribe the studies required to document Method performanceInterpret Method performance data and statistical data outcomes2 Context and definitionsRegulatory requirementsStudies required for analytical Verification and analytical Validation Outline 3 Context and Definitions4 Validation 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 testing5 Why Evaluate a Method ? Document initial performance: Reference when troubleshooting problems Quality assurance -to ensure results Helpful for clinical consultations Meet regulatory requirements 6 Laboratory 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, Requirem
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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