Create CAPA

Explore Job Aids for more help:

Job Aids

This section explains the process of creating a CAPA record from the Quality module. For creating a CAPA record, the originator user must have the Create CAPA action added from the User Management module.

To create a CAPA, follow the steps below.

  1. Within the Quality module, click on the CAPAs modal from the left-hand navigation pane.
  2. Click on the +Create button from the top menu bar and select a record type.

  3. On the Create CAPA form, fill in the mandatory details within Step 1: General Info and click on the Next button.

  4. Upload a file or folder as evidence and click on the Create Draft button.

  5. Once the CAPA is created, it is saved in the Draft status.
  6. Click on the CAPA title and click on the Submit for Review from the metadata panel.

  7. On the Submit for Review popup, enter a comment and click on the Submit button.

  8. Choose the appropriate workflow from the Workflows wizard and click on the Select button.

  9. Once the CAPA record is successfully transitioned to the first stage of the workflow. The Record Status, Workflow Stage, and Stage Status display statuses as configured in the workflow.

  10. Once the record enters the first stage of the approval workflow, the authority receives an email notification about the CAPA record with CAPA details and a clickable Open CAPA button to open the record.

Note:
  • Email notifications about record transitions are sent to the relevant authority types based on the Approval Workflow configuration.
  • The number of stages a CAPA record progresses through, along with its record and stage statuses, is determined by the configured Approval Workflow.

Create Related Records

In addition to creating a CAPA record using the CAPA modal, users can also create a related record linked to that CAPA.

Note:

Additionally, the originator must be an Admin user. If editor users are creating the CAPA, they must belong to the assigned team and hold the necessary authority.

To create a CAPA through a quality event, follow the steps below.

  1. Navigate to the Quality module > CAPAs tab and click on the CAPA title.
    1. From the metadata panel, click on the +Add Related dropdown and select any one option.
      1. Action Item
      2. Effectiveness Check
  3. The related record is visible in the Related tab of the records metadata panel.