Q06-3600 EQUIPMENT QUALIFICATION

Equipment Qualification is one of the first requirements to regulatory compliance to ensure equipment is fit for intended purpose. This package includes a Summary Report template, a Variance Report template and a process map (from design to qualification).

What is Equipment Qualification?

The design, construction and delivery of manufacturing systems and equipment into a facility requires a systematic approach in order to meet the user requirements and that of the relevant authorities like cGMP, local governing codes, law and regulations.

Equipment Qualification is the action of proving and documenting that equipment and ancillary systems are properly installed, work correctly, and actually lead to the expected results. This is to ensure that all critical aspects or acceptance criteria for its intended use are met. Qualification is part of the validation process, a regulatory compliance requirement.

NOTE:

This sub-category Facility & Equipment Requirements do share common templates as in E03-5000 Project Quality System (GEP):

To Open-Download-Print the PDF flowchart –>  E03-50-00_Project_Quality_Sys_Flowchart

E03-5000 Project Quality System Flowchart – Test, Commissioning & Qualification