The Symbiosis of21 CFR Part 11and FDA Predicate Rules in Regulatory Compliance Regardless of how any potentially forthcoming agency guidances might add to or change the focus of specific FDA 21 CFR Part 11 aspects in the future, there is one constant that will invariably hold true: it will a...
FDA regulations (other than part 11) are referred to in this guidance document as predicate rules...
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[...]proposed CSA complies with the requirement of Rule 57(4)(a) of the Rules of Procedure, i.e. whether a proposed CSA is relevant to the subject matter of the bill and tothesubjectmatter oftheclausetowhich it relates, she first forms a view on the scope of the bill, against whic...