Electronic Records, Electronic Signatures, and FDA Regulation Final Rule

Personswhouseclosedsystemstocreate,modify,maintain,ortransmit electronicrecordsshallemployproceduresandcontrolsdesignedtoensure

the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine (1, p. 13465).