| 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 | Filter housing must maintain pressure hold seal integrity during operation. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Pressure test report | Pass |
| URS-002 | Filter housing should be constructed of materials suitable for sterilization. | M | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Material certification | Pass |
| URS-003 | Filter housing must be compatible with the sterilization method used. | H | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Compatibility test report | Pass |
| URS-004 | Filter housing must be designed to prevent contamination. | H | DQ-004 | IQ-004 | OQ-004 | PQ-004 | Design review documentation | Pass |
| URS-005 | Filter housing must allow for easy access for maintenance and inspection. | M | DQ-005 | IQ-005 | OQ-005 | PQ-005 | Maintenance procedure documentation | Pass |