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Iso 13485 training11/2/2023 ![]() –The specific approach and activities associated with software validation and revalidation shall software used in the quality management system. Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on Octoand took effect on June 1, 1997. The organization shall document procedures for the validation of the application of computer software used in the quality management system. ![]() Quality management system software validation
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