Process Qualification

A process validation can be classified as the validation of controlled interaction of components, equipment, environment, software and personnel to produce a product or achieve an acceptable outcome. Autocal Ireland have fully qualified validation personnel that are thoroughly familiar with all of the current regulatory requirements and have the specialised expertise, project management skills and dedication to ensure that all of our clients processes are validated in compliance with all current guidelines. Our engineers can provide a turn-key solution for all of the initial process validation work or alternatively we can aid the upgrading of any process validation project.

Autocal provide a comprehensive exploration and evaluation service for all areas of process qualification, including:

  • Process development
  • Development reports and evaluations
  • User requirement specifications
  • Process performance qualification
  • Product performance qualification
  • Cleaning validation master plans
  • SOP documentation review

Contact us here for further information.