Articles by Mark Durivage
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How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem
7/19/2016
This article demonstrates two methods using the success-run theorem, which uses the confidence level (how sure we are) and reliability value (valid, consistent results) to determine appropriate statistically valid sample sizes for process validation.
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Risk-Based Approaches To Establishing Sample Sizes For Process Validation
6/14/2016
Using confidence, reliability, and acceptance quality limits (AQLs) to determine sample sizes for process validation are proven methods to ensure validation activities will yield valid results based upon an organization’s risk acceptance determination threshold, industry practice, guidance documents, and regulatory requirements.
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