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Procedure documentationConfiguring CAPA Locate this document in the navigation structure

 

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.

Prerequisites

Enabling CAPA Business Process
  1. Open the Customizing activity. Select   Governance, Risk, and Compliance   Process Control   Multiple-Compliance Framework   Configure Compliance Initiatives  . The Define Regulation Configuration screen appears.

  2. Select Define Regulation Type and choose Operational.

  3. Select Business Transaction.

  4. Choose CAPA.

  5. Select Enable.

  6. Choose Save.

Procedure

Enabling E-signature, Approval, and Audit Trail

The CAPA e-signature, approval, and audit functions are optional.

  1. Open the Customizing activity. Select   Governance, Risk, and Compliance   Process Control   Multiple-Compliance Framework   Configure Compliance Initiatives  . The Define Regulation Configuration screen appears.

  2. Select Define Regulation Type and choose Operational.

  3. Select Business Transaction.

  4. Choose CAPA.

  5. Select Settings.

  6. In the Settings table, select Activate for the following:

    • Audit Trail

    • CAPA Execution Approval

    • CAPA Plan Approval

    • E-signature

  7. Choose Save.

Assigning CAPA Roles to Users

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.

Using CAPA for Ad Hoc Issues

For ad hoc issue reporting, you have completed the Customizing activity   Governance, Risk and Compliance   Common Component Settings   Ad Hoc Issues   Enable CAPA by Regulation Type  .

For more information, see Identifying, Creating and Assigning Ad Hoc Issues.