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Certification and Qualification

The strict requirements of the authorities require complete equipment validations. With our services we provide objective proof with you that the regulatory requirements are met to your specific application.

An analysis system provides several methods and often uses a specially developed for this software. The validation includes the qualification of the device hardware, software and the analytical method. The monitoring is done by comparing with predefined acceptance criteria or control standards.

Use your device for the certification and qualification from our expertise as a manufacturer and benefit from our know-how. Whether it is a new installation or a change of location or a re-certification or re-qualification, we are there for you. Our certification service is based on a standardized procedure and exclusively performed by trained and certified specialists.

Installation qualification (IQ)

  • Initial installation or re-installation after a change of location
  • Evaluation of the system due to a given validation parameters
  • Comprehensive documentation of the individual steps

Functional Qualification (OQ)

  • at the expiration of functional qualification OQ
  • Periodic repetition of the qualification
  • Ensure a consistently validated status

System tests

  • Simple function test
  • Pre-defined acceptance criteria
  • Also suitable for non-validated environments

Contact

us-sales@buchi.com

Tel: +1 877 692 8244