You use e-signatures as a formal method of confirming actions and assigning accountability in the CAPA remediation process. The e-signature in Process Control complies with the requirements of 21 CFR Part 11.
You have enabled e-signatures in the Customizing activities.
For more information, see Configuring CAPA.
For the CAPA remediation process, the following roles and activities require e-signatures:
Role |
Action Requiring E-signature |
---|---|
CAPA Issue Owner |
|
CAPA Plan Approver |
|
CAPA Plan Execution Approver |
|
You commit the e-signature by entering your password in the e-signature screen and selecting Sign. You can also enter a comment.