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Glass Lined Reactor (GLR) – 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 GLR must maintain a temperature range suitable for chemical synthesis. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature Log URS-002…

Air Shower – 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 ID 1] Ensure air shower effectively de-dusts personnel before entry. [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1]…

Pass Box (Dynamic with HEPA) – 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 proper airflow during material transfer. H DQ-001 IQ-001 OQ-001 PQ-001 Airflow Measurement Report URS-002 Verify HEPA filter integrity.…

Bin/IBC Washer – 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 ID 1] The Bin/IBC Washer must effectively wash IBC/bin contact parts. [H/M/L] [DQ Test Ref 1] [IQ Test Ref…

Parts Washer (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 Parts Washer must maintain the wash temperature within specified limits. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature Log Pass…

Serialization & Aggregation System – 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 ID 1] [URS Statement 1] [Risk 1] [DQ Test Ref 1] [IQ Test Ref 1] [OQ Test Ref 1]…

Cartoning 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 ID 1] [URS Statement 1: Leaflet detection functionality] [Risk: H/M/L] [DQ Test Ref 1] [IQ Test Ref 1] [OQ…

Vision System (Label/Code Verification) – 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 Verify print/label correctness H DQ-001 IQ-001 OQ-001 PQ-001 Record-001 Pass/Fail URS-002 Ensure detection accuracy H DQ-002 IQ-002 OQ-002 PQ-002…

Induction Sealing 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 induction sealing machine must effectively seal liners. H DQ-001 IQ-001 OQ-001 PQ-001 Seal Integrity Report Pass URS-002 The…

Capper (Screw Cap) – 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 ID 1] The capper must accurately apply torque within the specified range. [H/M/L] [DQ Test Ref 1] [IQ Test…