Qualification

We ensure that our machines are capable of meeting the specified application for the intended use:

  • Established engineering methods and standards are applied throughout a project`s lifecycle to deliver the appropriate customer solutions and are implemented in our qualification processes.
  • Our qualification department establishes documented evidence which provides a high degree of assurance that our manufactured machines meet their predetermined specification and quality attributes and that our automated solutions are compliant with 21 CFR Part 11.
Qualification packages of WILCO AG

Qualification packages following GMP and GAMP 5 guidelines.

Documentation

We provide you with documentation which complies to the rules of the Machinery Directive 2006/42/EC and your requirements.