Process validation protocol - equipment qualification template checklist
An equipment qualification template is used to complete the process validation protocol by reporting the verification of the equipment::System final design against the user, functional, and::Or design specifications. use this process validation protocol - equipment qualification template to easily identify key items of equipment, utilities supply, and environmental requirements. take::Attach photos of all relevant equipment drawings such as mechanical drawings, electrical schematics, process and instrument drawings, etc.
What does this form include?
This form contains 15 sections:
Objective
Scope
Responsibility
Select key items of equipment
Select utilities supply
Take/attach photos of all relevant equipment drawings such as mechanical drawings, electrical schematics, process and instrument drawings, etc.
Equipment Qualification Protocol
- Are the user manual and spare parts list available?
- Are main components within the preventive maintenance program?
- Are primary instruments listed in the calibration program?
- Are instrument resolution and accuracy identified and adequate for process control range required?
- Are traceable standards used?
Select available SOPs
Select environmental requirements
Select key processes
Equipment Qualification Results
Conlusions
Protocol Author & Signature
Departmental Approval by
Quality Assurance Approval by
Use this template