VHP Decontamination Unit (if isolator/RABS) – 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 The VHP Decontamination Unit must achieve specified concentration levels for effective decontamination. H DQ-001 IQ-001 OQ-001 PQ-001 Concentration Log
URS-002 The system must maintain proper dwell time for the decontamination process. H DQ-002 IQ-002 OQ-002 PQ-002 Dwell Time Log
URS-003 Aeration must be verified to ensure residuals are below acceptable limits. M DQ-003 IQ-003 OQ-003 PQ-003 Aeration Log
URS-004 Residual levels must be monitored and recorded post-decontamination. H DQ-004 IQ-004 OQ-004 PQ-004 Residuals Log
URS-005 All logs must be maintained accurately for compliance and review. L DQ-005 IQ-005 OQ-005 PQ-005 Log Review Record
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