Barcode Scanner (GMP) – 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 barcode scanner must accurately capture data for identity verification. H DQ-001 IQ-001 OQ-001 PQ-001 Data capture logs
URS-002 The barcode scanner must maintain an audit trail of all scans performed. M DQ-002 IQ-002 OQ-002 PQ-002 Audit trail reports
URS-003 The system must ensure scan accuracy of 99% or higher. H DQ-003 IQ-003 OQ-003 PQ-003 Accuracy test results
URS-004 The barcode scanner must be validated for performance under varying conditions. L DQ-004 IQ-004 OQ-004 PQ-004 Performance validation reports
See also  Drum Tippler/Drum Tumbler – OQ Protocol