| 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 accurate stopper placement in syringes. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Logbook Entry | |
| URS-002 | Implement reject logic for stopper placement failures. | H | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Audit Trail Log | |
| URS-003 | Maintain an audit trail of all stopper placement actions. | M | DQ-003 | IQ-003 | OQ-003 | PQ-003 | System Logs | |
| URS-004 | Verify functionality of the stopper placement mechanism. | M | DQ-004 | IQ-004 | OQ-004 | PQ-004 | Test Report | |
| URS-005 | Ensure compliance with regulatory standards for syringe stoppers. | L | DQ-005 | IQ-005 | OQ-005 | PQ-005 | Compliance Certificate |