ARTICLES BY TOBIAS KUNERS OF KOENDERS
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The 5-Step Checklist For A More Mature, Robust Quality Management System8/20/2021
Whether you are preparing for a pre-approval inspection, have the corporate desire for continuous inspection readiness, or are engaged in a LEAN initiative to clean up and strengthen your quality management system (QMS), further maturing your QMS can be helpful to ensuring a robust, comprehensive, and compliant QMS.
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Bio/Pharma Maintenance 4.0: How To Get Started7/5/2019
Part 1 of this two-part series looked at the core aspects of Maintenance 4.0 and outlined a comprehensive maintenance process flow. In this second part, we will discuss how to get started with Maintenance 4.0, along with how to develop benchmark metrics that allow assessment of the gap between the current and desired states.
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Maintenance 4.0 – The Next Revolution In Bio/Pharma Manufacturing6/21/2019
The next stage in maintenance management, Maintenance 4.0, is to go beyond predictive to the initial stage of an asset — commissioning the assets and deploying the same tools and techniques to set the measures within the design specification from the beginning onward, and using indicative measures to keep the asset in its original design specification.