CFR 21 Part 11 Compliant: A term used to describe a practice or system that meets the requirements of the U.S. Code of Federal Regulations Title 21, Volume 1, Part 11. CFR 21 Part 11 Compliance is a stringent set of regulations used to protect digital records and electronic signatures from unauthorized access or manipulation. It ensures data integrity, authenticity, and auditability of electronic records by setting forth requirements for authentication, validation, and secure storage. Meeting these standards has become essential for organizations handling sensitive data due to increased scrutiny from both industry regulators and customers.