| 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 sterilize coated devices effectively. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Audit Trail Record | Pass |
| URS-002 | Cycle/dose mapping must be validated. | H | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Mapping Records | Pass |
| URS-003 | System must maintain an audit trail of all cycles. | M | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Audit Trail Log | Pass |
| URS-004 | System must operate within specified temperature range. | M | DQ-004 | IQ-004 | OQ-004 | PQ-004 | Temperature Logs | Pass |
| URS-005 | System must ensure no residuals on coated devices. | L | DQ-005 | IQ-005 | OQ-005 | PQ-005 | Residual Testing Report | Pass |