Turning a regulatory headache into a competitive advantage: Understanding 21 CFR Part 11 and EU Annex 11 compliance
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 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.
A key principle of any digital journey for a manufacturer, whether or not they are in the automotive supply chain, comes down to making effective use of production data. Learn how to ready your production line for Industry 4.0 with data-driven insights in this article, contributed by Sciemetric's Manufacturing IT Manager, Patrick Chabot.
The ASSEMBLY Show 2018 announces the inaugural Product of the Year winner, QualityWorX DataHub from Cincinnati Test Systems and Sciemetric. The DataHub is a simple, cost-effective tool for analyzing leak test data and performing test-to-test comparisons. The product aggregates data from multiple leak test instruments into an analytics database for real-time usage. Learn more in this article.
Cincinnati Test Systems and Sciemetric have brought the data management and analytics of Manufacturing 4.0 to leak and flow testing with their first collaboration as part of the TASI Group. Learn more about the QualityWorX CTS DataHub.
There are some instances where an acceptable leak rate is so small as to be practically zero. Few air leak test methods, such as pressure decay, have the necessary detection range. These situations call for a trace gas-based test method. Learn more in this article in Quality Magazine, written by Cincinnati Test Systems' Systems Engineer, Peter Bonyhati.
Rob Plumridge, Sciemetric leak application engineer, discusses best practices for leak testing e-vehicle batteries and how the 3520 Series Leak Test can be used for this purpose, with Assembly Magazine.
In this feature with Quality Magazine, Rob Plumridge, Sciemetric leak application engineer, discusses how to tackle the first “R” of Gage R&R for leak testing – repeatability. By focusing on repeatability first (before the other “R” – reproducibility), manufacturers can be certain they have addressed all the controllable variables that can impact the leak test, regardless of the equipment.
The editors of Design Engineering profile Sciemetric’s Model 3675, a turnkey station to boost the speed and accuracy of leak testing. The 3675 can combine up to three of Sciemetric’s 3520 Series Leak Test units in one stand, controlled by a single sigPOD controller.
A poor seal between the part to be tested and the leak test station can skew test results, allowing faulty parts to pass and perfectly good ones to be failed. In this feature published by Automation.com, Sciemetric leak test specialist Robert Plumridge explores how quality engineers can address the common issues with achieving a consistently reliable seal to ensure a reliable test.