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Method validation is a crucial process in analytical and testing laboratories to ensure that a specific test method is reliable, reproducible, and appropriate for its intended use. It involves a systematic assessment to confirm that the method consistently produces accurate, precise, and consistent results under defined experimental conditions.
This process is essential for demonstrating that a method can effectively measure the target analyte in a given sample matrix, whether for quality control, regulatory compliance, or research purposes. Method validation typically evaluates key performance characteristics such as accuracy, precision, specificity, sensitivity, linearity, range, and robustness.
By validating a method, laboratories can ensure confidence in their test results, support data integrity, and comply with regulatory requirements set by agencies like the FDA, EMA, or ISO. Ultimately, method validation safeguards the quality and reliability of analytical data used in pharmaceuticals, medical devices, food safety, and environmental testing.
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