Vial Crimping Machine – 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] The Vial Crimping Machine must seal vials with aluminum caps securely. [H/M/L] [DQ Test Ref] [IQ Test Ref] [OQ Test Ref] [PQ Test Ref] [Evidence/Record] [Result]
[URS ID] Crimp force must be within specified limits to ensure proper sealing. [H/M/L] [DQ Test Ref] [IQ Test Ref] [OQ Test Ref] [PQ Test Ref] [Evidence/Record] [Result]
[URS ID] Diameter of the crimped seal must meet specified dimensions. [H/M/L] [DQ Test Ref] [IQ Test Ref] [OQ Test Ref] [PQ Test Ref] [Evidence/Record] [Result]
[URS ID] Audit trail logs must be maintained for all crimping operations. [H/M/L] [DQ Test Ref] [IQ Test Ref] [OQ Test Ref] [PQ Test Ref] [Evidence/Record] [Result]
See also  Blow-Fill-Seal (BFS) Machine – Qualification Certificate Template

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