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Let’s say they use Minitab’s Capability Analysis Normal to perform the capability analysis.
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Specifically, at the time of this inspection there were two different versions of your CAPA & Customer Complaint procedure, SOP-200-104; however, no revision history was provided on the “Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i).“ … §820.70(i) (Production and Process Controls – Automated Processes).” …
A test case should contain: Many warning letters received by manufacturers cite a violation of this regulation.
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