IV Bag Form-Fill-Seal (FFS) 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 shall form IV bags at the specified forming temperature. H DQ-001 IQ-001 OQ-001 PQ-001 Forming Temp Record
URS-002 The machine shall fill IV bags with an accuracy of ±X%. H DQ-002 IQ-002 OQ-002 PQ-002 Fill Accuracy Record
URS-003 The machine shall ensure seal integrity of the filled IV bags. M DQ-003 IQ-003 OQ-003 PQ-003 Seal Integrity Record
URS-004 The machine shall provide alarms for critical failures. M DQ-004 IQ-004 OQ-004 PQ-004 Alarm Functionality Record
URS-005 The machine shall maintain an audit trail of operations. L DQ-005 IQ-005 OQ-005 PQ-005 Audit Trail Record
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