Tag: traceability matrix

VHP Generator – 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 VHP generator must achieve specified concentration levels for effective decontamination. [H/M/L] [DQ Test Ref 1] [IQ…

Isolator / RABS 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-001 Ensure the Isolator / RABS System provides a sterile environment for aseptic processing. H DQ-001 IQ-001 OQ-001 PQ-001 Documented…

CIP Skid – 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 CIP Skid must maintain a temperature range suitable for effective cleaning. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature Log…

SIP 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-001 System must achieve specified sterilization temperature. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature logs URS-002 System must maintain required pressure…