Users who click on a link for an existing CAPA or create a new one will be directed to this window. If you are the Issue Investigator, the CAPA Assignee or have special user permissions, you will have edit rights to this CAPA. If you need to make edits, you either need to get special permissions or simply change the CAPA Assignee to your own user.
- The Site Name, CAPA Type and CAPA ID are automatically created for the CAPA.
- Enter values for the Headline, Category and Implementation Date. These will be required for final Approval.
- Select an Assignee from the dropdown. If you set it to yourself, click the button to be able to see edit rights. Note that users will receive email and Dashboard notifications of new or lost assignments.
- Enter CAPA description. Don't forget that you can import a .docx file using the "Import File" button in the toolbar.
- Click the 'Upload More' link to attach any relevant attachments.
- CAPAs can be completed at any time using the button at the top of the page. Authorized users can see this button and clicking it will prompt the user for a p.11 compliant e-signature. Once completed the CAPA status will change to "Complete" and a workflow signature will be logged at the bottom of the CAPA window.
- Completed CAPAs can be unlocked for editing by clicking the link so long as the underlying issue is not CLOSED or VERIFIED.
- Comments: Any user with access to this CAPA can add comments. Click the button to add a comment. Comments are designated by default, but you can set any comment to 'All Reviewer' to share it with any external client/partner that you have shared the Issue with.