Vent Filter (Sterile Gas Filter Assembly) – 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 ID 1] Ensure the vent filter maintains sterility in tank vent. [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1] [OQ Test Ref 1] [PQ Test Ref 1] [Evidence/Record 1] [Result 1]
[URS ID 2] Verify integrity test pressure hold of the vent filter. [H/M/L] [DQ Test Ref 2] [IQ Test Ref 2] [OQ Test Ref 2] [PQ Test Ref 2] [Evidence/Record 2] [Result 2]
[URS ID 3] Document the performance of the integrity test. [H/M/L] [DQ Test Ref 3] [IQ Test Ref 3] [OQ Test Ref 3] [PQ Test Ref 3] [Evidence/Record 3] [Result 3]
See also  Dropper/Tip Insertion Machine – OQ Protocol