Smart.ESignature provides the electronic signature dialog described in 21 CFR Part 11: the record being signed, the meaning of the signature, the two signature components and the resulting manifestation.

The panel shows the record and its hash, asks for the meaning of the signature (§11.50), a user ID and a password (§11.200), and a reason when the procedure requires one. The component does not verify the password. It raises the signRequest event, the application checks the credentials against its user directory and calls accept() or reject(). After three rejections the panel is locked (§11.300(d)). The signature contains the hash of the signed record (§11.70), so a signature block under the record can report whether the record has changed.

Releasing a batch

The user directory in this demo contains jdoe (password operator1) and asmith (password qa2026). Only asmith is a QA approver. Releasing the batch requires an approval signature, after which the batch record is locked. Edit the yield after signing to see the signature block report that the record has changed. Enable continuous session to see a second signing by the same user ask for the password only.

Keyboard: Tab through the meaning, user ID, password, reason and Sign fields. Enter signs and Escape cancels. A rejection and the lock are announced to screen readers, and the manifestation is a status message.