Request Clarification

When a CAPA record progresses through the workflow stages, the assigned authorities at each stage can request clarification or create a query for the CAPA record, based on the workflow stage configuration.

To send a CAPA record for clarification, follow the steps below.

  1. Create a CAPA record as an originator user and send it to the first stage of the approval workflow by following the steps detailed in the Create CAPA section.

  2. As the authority in the first stage of the approval workflow, send the CAPA record to the second stage of the workflow, i.e., Implementation Approval by following the STEP 1 to STEP 6 from the Approve CAPA section.

  3. As the authority in the Implementation Approval stage, open the CAPA record and click on the Claim button.

  4. Click on the ‘Request Clarification’ button above the top of the quick view panel.

  5. On the ‘Request Clarification’ screen, mandatorily specify the recipients, add a description, and click on the ‘Request and Create Query’ button.

  6. On the record is successfully sent for clarification, the CAPA record displays the statuses as configured in the workflow.

  7. Additionally, the authority in the previous stage, i.e., Implementation, receives an email notification stating that a clarification is required on the CAPA record.

  8. As the authority in the Implementation stage, open the CAPA record and navigate to the ‘Queries’ tab in the quick view panel and click on the ‘>’ arrow.

  9. Click on the ‘Respond’ button.

  10. Enter the necessary response and click on the ‘Update and Save’ button.

  11. As the query initiator, i.e., assigned authority in the Implementation Approval stage, navigate to the Queries tab and click on the ‘Resolve’ button.

  12. On the ‘Resolve Query’ modal window, mandatorily enter comments and click on the ‘Resolve’ button.

  13. Once the Query is successfully resolved, the ‘Queries’ tab displays the status as resolved.

  14. Click on the ‘Query History’ button to view the activities related to the Query.

  15. Complete the record approval by following STEP 7 to STEP 12 detailed in the Approve CAPA section.