Cap Tightening 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-001 Cap Tightening Machine shall securely fasten caps on containers. H DQ-001 IQ-001 OQ-001 PQ-001 Installation Qualification Report Pass
URS-002 Machine shall have torque reject logic to ensure proper cap tightness. H DQ-002 IQ-002 OQ-002 PQ-002 Operational Qualification Report Pass
URS-003 Audit trail logs must be generated for each cap tightening process. M DQ-003 IQ-003 OQ-003 PQ-003 Audit Trail Log Review Pass
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Vial Washing 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-001 The equipment must effectively wash vials to remove contaminants before sterilization. H DQ-001 IQ-001 OQ-001 PQ-001 Validation Report Pass…