Beyond The Signature: CFR 21 Part 11 for Digital Record Integrity
As health and life sciences industries continue to shift from paper to digital, CFR 21 Part 11, a regulation issued by the U.S. Food and Drug Administration (FDA), has become a cornerstone of compliant electronic recordkeeping. It defines how organizations must manage electronic records and signatures to ensure they are as trustworthy, reliable, and legally valid as their paper counterparts.