Equipment and Utilities Qualification

The Equipment and Utilities Qualification is the process of proving with a high level of confidence that a device is able to operate consistently within the limits and tolerances which will be required during the production process. The concept of qualification is a part of a process validation, but it is focused on studying the fulfillment of technical requirements of each device for the development and implementation of equipment and utilities in industry. As with the other components of the production process, the equipment must be qualified in accordance with criteria established by current standards (FDA 21 CFR Part 211, item D; Annex 15 of the EU GMP, etc.) and also by the company.

parallax background

Major Qualification Advantages


  • Reduction of losses in the production process due to the greater stability of the equipment
  • Lower incidence of deviations in pre qualified equipment, preventing misuse
  • Greater rationalization and organization of activities
  • Increases process safety ehancing operator knowlegde
  • Contributes to the Validation Process, helping to ensure consistency in production
  • Reduces losses, waste and client complaints for possible quality deviations in production equipment
  • Adherence to national and international regulatory standards

Other products

Computerized Systems Validation I.T. Infrastructure Qualification Data Integrity VLMS - Validation Lifecycle Management System