Isolator / RABS System – Traceability Matrix (URS ↔ Tests)

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
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