Articles tagged with “predicate-rules”

21 CFR Part 11 Compliance: Requirements & Data Integrity

Explore FDA 21 CFR Part 11 compliance for electronic records and signatures. Learn about validation, audit trails, and data integrity enforcement trends.

35 min read

2/4/2026

21 cfr part 11 fda compliance data integrity electronic records electronic signatures computer system validation audit trails gxp predicate rules regulatory affairs