Glossary
Predicate rule
The underlying GxP regulation that requires a record to exist at all. Part 11 only governs records a predicate rule demands.
Predicate rules are the substantive regulations, the GMPs, GLPs and GCPs, that say keep this record, perform this review, retain this for this long. Part 11 never creates a record requirement; it only sets conditions for keeping a required record electronically.
The concept is the key that unlocks Part 11 scoping. For any record, ask: does a predicate rule require it, and is the electronic version the one relied upon? Two yeses and Part 11 applies. Everything else deserves a documented rationale rather than reflexive controls.