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Turning a regulatory headache into a competitive advantage: Understanding 21 CFR Part 11 and EU Annex 11 compliance

  • Article in MPO (Medical Product Outsourcing) Magazine
July 23, 2019

This article by Cincinnati Test Systems' David Kralovetz, market specialist for medical devices, discusses how to balance the implementation of Industry 4.0 monitoring and data analytics while abiding by the regulatory requirements laid out by the FDA's Title 21 CFR Part 11 and European Medicines Agency Annex 11. Read the article to learn more.

Helium 101: Making the most of trace-gas-based leak testing

  • Article in Quality Magazine
June 10, 2019

Helium leak testing is one of the oldest and most developed members of the family of trace-gas-based leak testing methods. This article in Quality Magazine by Cincinnati Test Systems' systems engineer, Peter Bonyhati, provides an overview of uses and benefits of the various trace gas methods; helium and its alternatives.

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