21 CFR Part 11Aug 20, 2026
21 CFR Part 11 did not change in 2026. Everything around it did.
Part 11 has been stable since 1997. The number of systems it applies to has not. QMSR took effect in February 2026, and the FDA's updated Computer Software Assurance guidance pulled cloud and SaaS tools formally into scope. Here is how to run the checklist so the answers stay true.
