Viewpoints On Life Sciences Quality & Compliance

Guidance to accelerate compliance, reduce quality costs and protect brand reputation, while increasing safety and efficacy of products.

Most Recent Viewpoints

Marc Fowler Oval Benley Saint Jean Veda Deshpande
Article: Connecting the Digital Thread Across the Quality Lifecycle

by Marc Fowler, Benley Saint-Jean and Veda Deshpande

Sachin Misra Nick Ward 2016
Article: AI in Pharma: Emerging Use Cases Across the Value Chain

by Sachin Misra and Nick Ward

David Wolf 2017 Max Huff
Article: Drive a Culture of Quality with Digital Quality Management

by David Wolf and Max Huff

David Wolf 2017 Dave Hadfield Blake Snell 2018 2
Article: Seven Leading Practices for Risk Management in Medical Device

by David Wolf, Dave Hadfield and Blake Snell

David Wolf 2017 Erin Shaffer John Hubert
Article: Leading Practices for EUDAMED and Basic UDI

by David Wolf, Erin Shaffer and John Hubert

Article: PLM-Enabled Quality Compliance for Medical Device Part 7 – Production & Process Controls

by Teresa Jacob

Bryan Kissel 2018 Chad Markle 2018
Article: Securing the IoMT – Nine Strategies You Can’t Afford to Overlook

by Bryan Kissel and Chad Markle

Article: PLM-Enabled Quality Compliance for Medical Device Part 1 – PLM at the Core

by Teresa Jacob

Article: PLM-Enabled Quality Compliance for Medical Device Part 2 – Design Controls

by Teresa Jacob

Article: PLM-Enabled Quality Compliance for Medical Device Part 3 – Records, Documents and Change Controls

by Teresa Jacob

Article: PLM-Enabled Quality Compliance for Medical Device Part 4 – CAPA

by Teresa Jacob

Article: PLM-Enabled Quality Compliance for Medical Device Part 5 – Material Controls

by Teresa Jacob

Article: PLM-Enabled Quality Compliance for Medical Device Part 6 – Equipment & Facility Controls

by Teresa Jacob

David Wolf 2017
Article: How PLI Can Decrease the Cost of Quality and Compliance

by David Wolf

David Wolf 2017
Article: Streamlining your EU MDR Compliance Journey

by David Wolf

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