To use CAPA remediation, you must enable the CAPA business process in the Customizing activities and assign the CAPA relevant roles to users. You can also choose to enable e-signature, approval, and audit trail.
Open the Customizing activity. Select
. The Define Regulation Configuration screen appears.Select Define Regulation Type and choose Operational.
Select Business Transaction.
Choose CAPA.
Select Enable.
Choose Save.
The CAPA e-signature, approval, and audit functions are optional.
Open the Customizing activity. Select
. The Define Regulation Configuration screen appears.Select Define Regulation Type and choose Operational.
Select Business Transaction.
Choose CAPA.
Select Settings.
In the Settings table, select Activate for the following:
Audit Trail
CAPA Execution Approval
CAPA Plan Approval
E-signature
Choose Save.
To authorize users to perform CAPA approval activities, you must assign them the following roles:
CAPA Plan Approver
CAPA Execution Approver
You assign the roles at the compliance initiative level. For more information, see Assigning Users to Roles for Corporate and Organization Objects.
For ad hoc issue reporting, you have completed the Customizing activity
.For more information, see Identifying, Creating and Assigning Ad Hoc Issues.