
The Role of FDA Predicate Rules in 21 CFR Part 11 Compliance
July 7, 2022
By James Jardine, Staff Writer, MasterControl
Thanks to 21 CFR Part 11, the FDA recognizes that digitized records and signatures are just as valid as those maintained on paper. But that doesn’t mean Part 11 supersedes the requirements previously established in FDA predicate rules. Find out why your company’s compliance is dependent on understanding the applicable predicate rules.
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