FDA Computer System & Software Validation - What You’ve Known For 20 Years Is Changing
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FDA Computer System & Software Validation - What You’ve Known For 20 Years Is Changing
In 2019, FDA will be releasing a new, draft guidance “Computer Software Assurance for Manufacturing, Operations, and Quality System Software” that updates 20 year legacy guidance documents found in 21 CFR Part 11 relating to medical device computer system validation and software validation.
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