What is MV?

Summary: Method validation and verification (MVs) are essential quality processes in laboratories to ensure methods deliver accurate and reliable results under specific conditions.

Why Perform MV:

Method Validation and Verification are essential to confirm that a laboratory method delivers accurate, reliable, and reproducible results tailored to its intended purpose. It prevents errors that could compromise diagnoses or product quality and ensures the method performs consistently across different samples, instruments, and operators. Additionally, validation fulfills regulatory and accreditation requirements by providing documented proof of method suitability and compliance. Overall, method validation underpins confidence in laboratory data and supports sound decision-making.

Understanding Method Validation:

Method validation is a thorough evaluation process performed when a laboratory adopts a new unvalidated method, establishes a reference method, develops Laboratory Developed Tests (LDTs), or meets regulatory requirements. It confirms that the method performs as intended by assessing key parameters such as accuracy, precision, sensitivity, and specificity. LDTs, being internally developed tests without commercial standards, particularly require validation to ensure consistent and trustworthy results.

Understanding Method Verification:

Method verification confirms that an already validated method functions correctly in a new laboratory setting or after modifications. It involves comparing results against a known true value from a previously validated comparative method, often a reference method. Verification is necessary when introducing new instruments or altering existing methods to maintain confidence in test outcomes without repeating full validation.

Supporting Method Validation and Verification:

Managing validation and verification involves detailed documentation, data comparison, and compliance with regulatory standards. Software tools designed for these processes can help organize workflows, track changes, and maintain records, facilitating smoother execution and audit readiness.

Conclusion:

Method validation and verification are foundational to laboratory quality assurance. Clear understanding and systematic execution of these processes ensure that laboratory methods remain reliable and compliant across different settings and over time.