Title 21 CFR Part 11: Predicate Rules
What is a predicate rule? Predicate rules are rules that help you determine if something applies to you or not. In the case of part-11 compliance, a predicate rule is some other law that dictates what needs to be retained, how long it is needed, any other constraints with respect to electronic systems. An example is when you are building a system, you need to ask, is this information regulated? If the answer is yes.. then part-11 applies, along with some constraints like the e-signatures part only applies to records that needed to be “signed” in paper form, and you are replacing this with an electronic system.
What other laws could apply, how do you know?
Well in any regulated industry there are the CFR’s (federal regulations) which spell out in detail the specifics, and other acts as well (Food, Drug and Cosmetic Act, or the Public Health Service Act and any ammendments) in our case of 21 CFR Part 11, we look at the GXPs (Good Clinical Practices, Good Manufacturing Practices)