What this covers
Deviations, changes, complaints, audits, and similar processes use workflow tasks after Send for Approval. Approvers work in My Tasks, not by picking Approve/Reject from the lifecycle menu while In Approval.
Start approval
- Open the parent record (e.g. deviation).
- Workflow and State Change → Send for Approval.
- Pick participants in the start dialog.
- Record enters In Approval (or equivalent).
Complete tasks
Approvers open tasks in My Tasks:
| Verdict | Effect |
|---|---|
| Approve | Workflow advances per definition |
| Reject | Returns to prior state; reason captured on task completion |
While In Approval, the lifecycle state menu must not expose direct approve/reject user actions.
E-signatures
When enabled on the object, completing a task may require Part 11 e-signatures. Follow task prompts; do not sign for another user.
Investigations and CAPA
- CAPA actions are child records; completing them does not auto-close the parent.
- Advance the parent when its lifecycle allows.
- After the parent is closed, open a continuous improvement CAPA instead of reopening the parent.
FAQ
| Symptom | What to check |
|---|---|
| Approve in menu but blocked | Use My Tasks for QMS approval |
| Rejection reason missing | Enter on reject task completion |
| Parent still open after actions | Expected — check next lifecycle action |