| URS ID | URS Statement | Risk (H/M/L) | DQ Test Ref | IQ Test Ref | OQ Test Ref | PQ Test Ref | Evidence/Record | Result |
|---|---|---|---|---|---|---|---|---|
| URS-001 | The machine must accurately fill ear drop bottles to the specified volume. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Calibration Certificate | |
| URS-002 | The machine must have reject logic for out-of-spec fills. | M | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Validation Report | |
| URS-003 | The machine must maintain an audit trail for all filling operations. | L | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Audit Trail Log |