eSignature

While 21 CFR Part 11 does not require the use of eSignatures, it does provide regulations for their use when they are used. In this case, the system must ensure that eSignatures:

• Are irrevocably linked to their respective records.
• Show the full name of the signer, date and time, as well as the meaning of, or reason for, the signature (such as review, approval, responsibility, or authorship).
• Are present whenever the signed records are displayed or printed.

Figure 1 The systems enables selective or batch signing of records, and satisfies regulatory requirements for signature authentication and meaning.

Figure 2 Electronic signatures are linked to their respective records, and include the name, date/time, and meaning of the signature.

Figure 3 Signature on a report.