| 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 | System must achieve specified sterilization temperature. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Temperature logs | |
| URS-002 | System must maintain required pressure during sterilization. | H | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Pressure logs | |
| URS-003 | System must hold sterilization conditions for specified duration. | M | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Hold time records | |
| URS-004 | System must generate audit trail logs for all operations. | L | DQ-004 | IQ-004 | OQ-004 | PQ-004 | Audit trail logs |