| 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 | Ensure accurate needle attachment to syringe. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Audit Trail Log | Pass |
| URS-002 | Maintain assembly accuracy within specified tolerances. | M | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Calibration Records | Pass |
| URS-003 | Provide an audit trail for needle assembly process. | H | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Process Logs | Pass |
| URS-004 | Ensure system alerts for assembly errors. | M | DQ-004 | IQ-004 | OQ-004 | PQ-004 | Error Reports | Pass |
| URS-005 | Verify system performance under peak load conditions. | L | DQ-005 | IQ-005 | OQ-005 | PQ-005 | Performance Test Records | Pass |