Grade A/B/C/D Cleanrooms (Facility Qualification) – 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 ISO class recovery is within specified limits H DQ-001 IQ-001 OQ-001 PQ-001 Recovery Test Report
URS-002 Verify Air Changes per Hour (ACH) meet requirements M DQ-002 IQ-002 OQ-002 PQ-002 ACH Test Report
URS-003 Monitor Differential Pressure (DP) to maintain integrity H DQ-003 IQ-003 OQ-003 PQ-003 DP Test Report
URS-004 Control Temperature (Temp) within defined range M DQ-004 IQ-004 OQ-004 PQ-004 Temperature Log
URS-005 Maintain Relative Humidity (RH) within acceptable limits M DQ-005 IQ-005 OQ-005 PQ-005 Humidity Report
URS-006 Verify Airflow Visualization using smoke studies L DQ-006 IQ-006 OQ-006 PQ-006 Airflow Visualization Report
See also  Lyophilizer Vacuum System – DQ Protocol