Process Validation Protocol - Equipment Qualification Template

Equipment Qualification Protocol

Objective

Scope

Responsibility

Select key items of equipment

Specify

Select utilities supply

Specify

Take/attach photos of all relevant equipment drawings such as mechanical drawings, electrical schematics, process and instrument drawings, etc.

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
Specify
Select key processes

Specify

Completion

Equipment Qualification Results

Conlusions

Protocol Author & Signature
Departmental Approval by
Quality Assurance Approval by
Please note that this checklist is a hypothetical example and provides basic information only. It is not intended to take the place of, among other things, workplace, health and safety advice; medical advice, diagnosis, or treatment; or other applicable laws. You should also seek your own professional advice to determine if the use of such checklist is permissible in your workplace or jurisdiction.