| 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 apply an overwrap to IV bags without compromising seal integrity. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Seal integrity test report | |
| URS-002 | The machine must maintain the specified temperature during the sealing process. | H | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Temperature calibration records | |
| URS-003 | The machine must ensure proper dwell time for sealing. | M | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Dwell time validation report | |
| URS-004 | The machine must incorporate reject logic for defective bags. | M | DQ-004 | IQ-004 | OQ-004 | PQ-004 | Reject logic test results | |
| URS-005 | The machine must maintain an audit trail of all operations. | L | DQ-005 | IQ-005 | OQ-005 | PQ-005 | Audit trail records |