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The document provides a comprehensive guide on Test Method Validation (TMV) specifically for the medical device industry. It outlines the objectives, processes, and best practices necessary to plan, execute, and document TMV activities to ensure compliance with validation requirements. The authors, Mai Nguyen-Misra and George Omae from Medtronic, emphasize the importance of demonstrating that test methods are suitable for their intended purpose and capable of producing valid results. The document includes sections on TMV overview, types, process flow, maintaining validated states, and a case study illustrating practical application.

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What is the test method validation?

Test methods are the set of procedures defined to execute the tests. Test Method Validation means establishing by objective, evidence that the test method consistently produces a desired result required to satisfy the intended use.

What is the 21 CFR test method validation?

21 CFR 820.3 states: Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

What is the 21 CFR 820.3 definition of validation?

Definitions 21 CFR 820.3 (z)(1) Process Validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

What is the test validation method?

Test validation is the process of verifying whether the specific requirements to test development stages are fulfilled or not, based on solid evidence. In particular, test validation is an ongoing process of developing an argument that a specific test, its score interpretation or use is valid.

What is the TMV process validation?

Test method validation is the process of demonstrating that a particular analytical method is suitable for its intended purpose and consistently produces reliable results.