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QM System

Quality is not a Coincidence! - (Qualität ist Kein Zufall)

Our Mission: To deliver first class services in the GLP/GMP compliant pathogen safety testing worldwide!

At ViruSure our success can only be assured through a total commitment to test quality, customer service and regulatory compliance.

Quality needs to be planned from the beginning through the completion for any successful study. It was with this goal that the state of the art risk based Quality System was designed, which covers not only the legal aspects of GMP, GLP, EHS etc, but also components of ISO 9001:2000 in order to ensure a strong focus on customer service and communication.

We commit and ensure that from preparation of the contract through to completion of the audited final report and beyond, all work will be performed to the highest quality.

Our QA group is actively involved in all aspects of the company, and potential clients are welcome to inspect our laboratory space and quality systems, which have continually received excellent feedback from our customers and the regulatory authorities. ViruSure is certified by the Austrian AGES for both GMP and GLP compliance (this includes both in vitro and in vivo based studies).

The established quality system includes the following aspects:

  • GMP/GLP compliant facilities and systems (for copies of our certificates click here)
  • Documented training of staff
  • Regular internal inspections by QA experts
  • Traceable and secure receiving, storage and analysis of test articles
  • Using only controlled and traceable materials
  • Validated assays & processes
  • Calibrated and validated equipment and instrumentation installed through IQ/OQ/PQ
  • System, equipment and analytical SOPs
  • Controlled Study Plans and Final Reports
  • Change Control Procedures
  • Stringent Non-Conformance Procedures
  • Archiving of all documents for a minimum of ten years

For more information on our Quality System please contact us here

Virusure GmbH

Donau-City-Straße 1, A-1220 Vienna, Austria.
Phone: +43-(0)1-2699120
Fax: +43-(0)1-2699120/22