| 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 | Verify shelf temperature control during lyophilization. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Temperature log files | |
| URS-002 | Ensure vacuum pressure is maintained throughout the process. | H | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Vacuum pressure records | |
| URS-003 | Validate the cycle profile for lyophilization. | M | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Cycle profile documentation | |
| URS-004 | Confirm audit trail functionality for process monitoring. | L | DQ-004 | IQ-004 | OQ-004 | PQ-004 | Audit trail logs |