Module GLP-16 · Version 1.0
Planning a Validation or Verification Study
Before a new or modified method touches a patient specimen, the laboratory has to know which studies it owes: a short verification of an unmodified FDA-cleared method, or a full validation of a modified or laboratory-developed one. Classify the method, match each performance characteristic to its pathway, work an EP15-style precision and bias verification, and close the readiness gate before go-live.
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Who this module is for
Laboratory scientists, technical supervisors, and quality staff planning or reviewing method validation and verification studies
Learning objectives
- Define intended use, measurand, matrix, population, reportable range, sites, instruments, and claims for a method under study
- Determine which performance characteristics require validation versus verification for a given method status
- Write predefined acceptance criteria, a sample strategy, an analysis plan, assigned responsibilities, and a failure decision before data collection begins
How completion works
Mark every required section done and answer every knowledge check in those sections correctly. The final save completes the module automatically.
Sources
15 sources
1. Code of Federal Regulations, Title 42, Part 493, Subpart K, Section 493.1253, Standard: Establishment and verification of performance specifications
Source note · federal regulation
2. Centers for Medicare & Medicaid Services, Survey and Certification Letter 15-17, guidance on laboratory modification of FDA-cleared/approved test systems under CLIA
Source note · federal guidance
3. Centers for Medicare & Medicaid Services, CLIA Verification of Performance Specifications guidance document
Source note · federal guidance
4. U.S. Food and Drug Administration, Executive Summary, verification and validation distinctions for FDA-cleared test systems
Source note · federal guidance
5. U.S. Food and Drug Administration, Laboratory Developed Tests FAQs, Phaseout Policy and Enforcement Discretion Policies, and Federal Register final rule Medical Devices; Laboratory Developed Tests; Implementation of Vacatur (September 19, 2025)
Source note · federal regulation
6. College of American Pathologists. All Common Checklist, COM.40300 Verification of Test Performance Specifications - FDA-cleared/approved (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
7. CLSI EP19, A Framework for Using CLSI Documents to Evaluate Medical Laboratory Test Methods, 3rd edition (2022, current)
Source note · consensus standard
8. CLSI EP15, User Verification of Precision and Estimation of Bias, 3rd edition (A3, 2014, current)
Source note · consensus standard
9. CLSI EP05, Evaluation of Precision of Quantitative Measurement Procedures, 4th edition (published December 2025)
Source note · consensus standard
10. CLSI EP06, Evaluation of Linearity of Quantitative Measurement Procedures, 2nd edition (2020)
Source note · consensus standard
11. CLSI EP09c, Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd edition (2018)
Source note · consensus standard
12. CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, 2nd edition (2012, reaffirmed 2017)
Source note · consensus standard
13. CLSI EP12, Evaluation of Qualitative, Binary Output Examination Performance, 3rd edition (2023)
Source note · consensus standard
14. College of American Pathologists. All Common Checklist, COM.40350 Validation of Test Performance Specifications - Modified FDA-cleared/ (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
15. College of American Pathologists. All Common Checklist, COM.40475 Method Validation and Verification Approval - Nonwaived Tests (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard