Encapsulation Efficiency Measurement Setup (HPLC/UPLC + separation) – 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 Ensure accuracy of encapsulation efficiency measurements H DQ-001 IQ-001 OQ-001 PQ-001 Calibration certificate
URS-002 Verify linearity of assay results M DQ-002 IQ-002 OQ-002 PQ-002 Linearity test report
URS-003 Confirm integration of chromatographic data M DQ-003 IQ-003 OQ-003 PQ-003 Integration audit trail
URS-004 Maintain audit trail for data integrity H DQ-004 IQ-004 OQ-004 PQ-004 Audit trail report
See also  CIP System – PQ Protocol

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