| 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 equipment must effectively wash vials to remove contaminants before sterilization. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Validation Report | Pass |
| URS-002 | The wash pressure must be maintained within specified limits. | H | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Calibration Records | Pass |
| URS-003 | The wash temperature must be controlled and monitored during operation. | M | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Temperature Logs | Pass |
| URS-004 | The equipment must demonstrate effective particulate removal from vials. | H | DQ-004 | IQ-004 | OQ-004 | PQ-004 | Particulate Testing Results | Pass |
| URS-005 | The PLC must log all critical parameters during the wash cycle. | M | DQ-005 | IQ-005 | OQ-005 | PQ-005 | PLC Log Records | Pass |