TEM / SEM (as GMP-supporting analytics) – 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 resolution calibration is performed to verify imaging capabilities. H DQ-001 IQ-001 OQ-001 PQ-001 Calibration Certificate
URS-002 Verify image integrity meets predefined standards for morphology characterization. M DQ-002 IQ-002 OQ-002 PQ-002 Image Integrity Report
URS-003 Confirm the system is capable of characterizing various sample morphologies. L DQ-003 IQ-003 OQ-003 PQ-003 Characterization Results
URS-004 Ensure that all calibration and validation records are maintained for audit purposes. M DQ-004 IQ-004 OQ-004 PQ-004 Validation Master Plan
See also  Dispensing Booth (Downflow) – DQ Protocol