Cartridge Filling 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 machine must accurately fill the specified volume of sterile drug into cartridges. H DQ-001 IQ-001 OQ-001 PQ-001 Filling Accuracy Report [Pass/Fail]
URS-002 The machine must include reject logic for out-of-spec fills. M DQ-002 IQ-002 OQ-002 PQ-002 Reject Logic Test Report [Pass/Fail]
URS-003 The machine must maintain an audit trail for all filling operations. L DQ-003 IQ-003 OQ-003 PQ-003 Audit Trail Log Review [Pass/Fail]
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