Transcription of Method Validation and Verification - University of Utah
{{id}} {{{paragraph}}}
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 ?
Feb 12, 2018 · • Precision, accuracy, reportable range and reference interval must be evaluated, at a minimum, for all nonwaived tests before patient use • No “one size fits all” approach to validation/verification 41
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
{{id}} {{{paragraph}}}