Regulatory requirements for verification and validation are complex and often cause confusion among clinical laboratorians, especially in regards to quantitative molecular assays. This presentation will discuss verification and validation requirements as defined by the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP). Calibrations and standards, including calibration, calibration verification, analytical measurement range (AMR) verification and the importance of quality standards, will also be discussed.
1. Define verification and validation
2. Define the verification requirements for unmodified FDA-cleared/approved tests
3. Discuss the validation requirements for modified FDA-cleared/approved tests and laboratory developed tests
4. Describe calibration methods and standards for quantitative assays