| 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 the Isolator / RABS System provides a sterile environment for aseptic processing. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Documented evidence of sterile environment validation. | Pass/Fail |
| URS-002 | Verify the pressure integrity of the isolator system during operation. | H | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Pressure integrity test results. | Pass/Fail |
| URS-003 | Confirm VHP cycle audit trail logs are maintained and accessible. | M | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Audit trail log records. | Pass/Fail |