Electronic Signatures in Pharma ELN: Achieving 21 CFR Part 11 Compliance
January 8, 2026
Electronic signatures in pharmaceutical laboratories carry the same legal weight as handwritten signatures on paper documents. When a researcher signs an experiment, a supervisor approves a method validation, or a quality unit authorizes batch release, that signature creates legal accountability. The signer cannot later claim “I didn’t authorize that” or “someone else used my account.” Yet many laboratories implement electronic…










