| 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 lyophilizer shall maintain a shelf temperature within specified limits during the freeze-drying process. | M | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Temperature Log | Pass/Fail |
| URS-002 | The lyophilizer must achieve and maintain the required vacuum pressure throughout the cycle. | H | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Pressure Log | Pass/Fail |
| URS-003 | The system must provide an audit trail for all critical parameters during the freeze-drying process. | M | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Audit Trail Report | Pass/Fail |