Company: Aap Implantate AGProduct: Orthopedic implants Date: 7/16/04 Failure to validate, according to an established protocol, computer software for its intended use, when that software is used as part of the Quality System or part of production as required by 21 CFR 820.70(i), Automated Processes. The regulation under 21 CFR 820.70(i) requires that when computers...Read More
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