Documenting approval of your investigation and action plan is simple. Make final selections for the site and verification steps and click the Launch Workflow button! After it's launched, the Issue state is changed to 'Awaiting Approval' and the application seeks immediate approval from all investigators and CAPA Assignees. Once these are obtained, the app launches the 'Site Approval' workflow. Once completed, any listed Internal or External Client approvals required must be completed before the Issue can go into 'Implementation' state. After all CAPAs are completed, the Issue state is set to 'Closed' and the application automatically launches the verification steps you defined up front. Once all verification steps are complete, the Issue State is set to 'Verified'.
- Required: The application requires all issue investigators as signatories and adds them by default.
- Required: All CAPA Assignees for incomplete CAPAs must also review/approve the documents or their assignments. These items must all have a valid Implementation date and Assignee listed.
- Each site can define it's own approval workflow for Issue approval. You have to select from the authorized users listed. If no users are listed, ask your system administrator to add users.
- Internal & Client Approval users who were designated as "Required Approval" will automatically appear here.
- Determine how many verification steps you want to add and select users for each step.
- Click the Launch Workflow button.
- Comments: Any user with access to this Issue 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.
Note: When a workflow is active or complete, the issue will be locked from editing by all parties save for comments—you see Clicking on this link will unlock the Issue, erase any completed Issue workflows; related CAPAs will remain 'Complete' or revert to DRAFT.