| 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 equipment shall apply drug-polymer coating uniformly across the stent surface. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Coating thickness measurements | |
| URS-002 | The equipment shall maintain specified spray parameters during operation. | M | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Spray parameter logs | |
| URS-003 | The equipment shall record drying time for each batch of coated stents. | L | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Drying time records |