| 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 the filtration skid maintains sterility throughout the process. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Validation Report | Pass |
| URS-002 | Verify that the flow rate meets specified criteria. | M | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Flow Rate Test Record | Pass |
| URS-003 | Confirm that the differential pressure (DP) is monitored and logged. | H | DQ-003 | IQ-003 | OQ-003 | PQ-003 | DP Monitoring Log | Pass |
| URS-004 | Ensure an integrity test is performed on the filtration membrane. | H | DQ-004 | IQ-004 | OQ-004 | PQ-004 | Integrity Test Report | Pass |
| URS-005 | Document an audit trail for all critical parameters. | M | DQ-005 | IQ-005 | OQ-005 | PQ-005 | Audit Trail Log | Pass |