21 CFR Part 11 Compliance in the Laboratory: Ensuring Trustworthy Electronic Records and Signatures
June 12, 2025
In regulated laboratory environments, maintaining the integrity, security, and traceability of electronic records is essential—not only for operational excellence but for legal compliance. That’s where 21 CFR Part 11 comes in. Enforced by the U.S. Food and Drug Administration (FDA), this regulation defines how electronic records and electronic signatures must be managed to be considered as trustworthy and reliable as…