Isolator / RABS (NDDS Filling) – 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 Verify leak integrity of the isolator H DQ-001 IQ-001 OQ-001 PQ-001 Leak Integrity Test Report Pass
URS-002 Ensure glove integrity for aseptic operations M DQ-002 IQ-002 OQ-002 PQ-002 Glove Integrity Test Report Pass
URS-003 Validate VHP cycle audit trail H DQ-003 IQ-003 OQ-003 PQ-003 VHP Cycle Audit Report Pass
See also  Lamination Machine – Traceability Matrix (URS ↔ Tests)

Also Check:

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