Equipment Validation

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…

Case Packer – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Case Packer Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Packaging/Secondary Qualification Flags Design Qualification (DQ): Yes Installation Qualification (IQ): Yes Operational Qualification (OQ): Yes Performance Qualification (PQ): Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol…