Colloid Mill (if used) – 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 Colloid Mill must effectively reduce particle size to specified limits. H DQ-001 IQ-001 OQ-001 PQ-001 Validation Report Pass
URS-002 The equipment must maintain gap speed for consistent particle size control. M DQ-002 IQ-002 OQ-002 PQ-002 Calibration Certificate Pass
URS-003 The Colloid Mill must be capable of operating within defined temperature limits. L DQ-003 IQ-003 OQ-003 PQ-003 Temperature Log Pass
URS-004 The equipment must have a user-friendly interface for operation. M DQ-004 IQ-004 OQ-004 PQ-004 User Training Records Pass
See also  Sachets & Stick Packs (Non-Sterile) – Qualification Certificate Template