Structure
- A test protocol holds one or more test scripts.
- Scripts have steps with optional instructions.
- Scripts need pre-approval before execution.
Link requirements to scripts/steps in the trace matrix (RTM).
Separation of duties
| Role | Typical duty |
|---|---|
| Author / owner | Build script, link requirements, submit pre-approval, start execution (not record results for executor) |
| Executor | My Tasks — record results step by step |
| Independent reviewer | Sharing independent_reviewer — not the executor |
| Approver | Pre-approval and final approval tasks — executor cannot self-approve |
Do not combine execute + independent review + final approval on one person.
Pre-approval through execution
- Start Authoring → maintain steps → Submit for Pre-Approval.
- Approver task → Pre-Approved.
- Lead Start Test Execution / Start Execution Workflow with executor assigned.
- Executor records Actual Results in My Tasks.
- Independent review → final approval → Post-Approved (or vault terminal state).
Do not use lifecycle state menu approve/reject while In Approval.
Discrepancies
Execution issues → validation discrepancy → investigation and CAPA. Blocking discrepancies may prevent activity completion.
Close an activity
Before Complete activity, the system checks deliverables and script conclusions. Failure keeps the activity in place.
FAQ
| Symptom | What to check |
|---|---|
| Executor has no task | Execution workflow started; executor fields |
| IR rejected | Executor ≠ reviewer |
| Approved but cannot execute | Pre-approval needs separate execution start |