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Coding Machine (Inkjet/Laser) – Qualification Execution Checklist
Qualification Execution Checklist Equipment: Coding Machine (Inkjet/Laser) Subcategory: Nasal & Otic Products (Sterile / Non-Sterile) Area: Packaging DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-Start Training completed SOPs reviewed URS approved RA approved Calibration/PM Status Verification Calibration status verified PM status…
Case Packer – 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 the case packer maintains pack integrity throughout the packing process. [H/M/L] [DQ Test Ref 1] [IQ…
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]…