| 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 | Ensure audit trail access is logged and retrievable. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Audit Trail Logs | Pass |
| URS-002 | Control access to the serialization system to authorized personnel only. | H | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Access Control Reports | Pass |
| URS-003 | Maintain data integrity throughout the serialization process. | M | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Data Integrity Checks | Pass |
| URS-004 | Ensure traceability of products through unique identifiers. | M | DQ-004 | IQ-004 | OQ-004 | PQ-004 | Traceability Reports | Pass |
| URS-005 | Validate the system’s ability to generate and read serialization codes. | L | DQ-005 | IQ-005 | OQ-005 | PQ-005 | Validation Reports | Pass |