FDA Predicate Rules: The Key to 21 CFR Part 11 Compliance for Life Sciences Quality Managers
September 10, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
FDA 21 CFR Part 11 does not invalidate the predicate rules that were established for paper-based document management systems, it simply builds upon and reinforces those existing rules in digital platforms. Learn about the symbiotic nature of Part 11 and FDA predicate rules and discover how an awareness of their relationship is fundamental to easing compliance burdens.
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