| 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 microfluidic mixer must ensure controlled nanoparticle formation. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Validation Report 001 | |
| URS-002 | The mixer must maintain specified flow ratio for optimal mixing. | H | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Validation Report 002 | |
| URS-003 | The system must control the total flow rate during operation. | M | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Validation Report 003 | |
| URS-004 | The mixer must operate within the specified temperature range. | M | DQ-004 | IQ-004 | OQ-004 | PQ-004 | Validation Report 004 | |
| URS-005 | The mixing time must be controlled to ensure product consistency. | L | DQ-005 | IQ-005 | OQ-005 | PQ-005 | Validation Report 005 | |
| URS-006 | The system must monitor backpressure during operation. | M | DQ-006 | IQ-006 | OQ-006 | PQ-006 | Validation Report 006 | |
| URS-007 | An audit trail must be maintained for all operations performed. | H | DQ-007 | IQ-007 | OQ-007 | PQ-007 | Validation Report 007 |