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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.

Prerequisites

You have enabled e-signatures in the Customizing activities.

For more information, see Configuring CAPA.

Features

For the CAPA remediation process, the following roles and activities require e-signatures:

Role

Action Requiring E-signature

CAPA Issue Owner

  • Submit CAPA plan for approval

CAPA Plan Approver

  • Approve plan

  • Send plan back to issue owner for rework

  • Cancel plan

CAPA Plan Execution Approver

  • Approve plan execution

  • Send plan back to issue owner for re-execution

You commit the e-signature by entering your password in the e-signature screen and selecting Sign. You can also enter a comment.