| Requirement | Yes | No | Comments |
|---|---|---|---|
| Access request is formally documented and authorized | |||
| Requested access aligns with job role and responsibilities | |||
| Least-privilege access principle applied | |||
| Segregation of duties evaluated and no conflicts identified | |||
| System is GMP / Part 11 relevant | |||
| Role-based training completed (or scheduled) |
| Approval Level | Name | Decision | Date | Signature |
|---|---|---|---|---|
| System Owner | ||||
| IT Administrator | ||||
| Quality Unit (QA) |
| Confirmation Item | Completed | Notes |
|---|---|---|
| Access provisioned exactly as approved | ||
| User notified of access activation | ||
| Access recorded in system access register / audit trail |