The FDA has recognized that current perceptions and approaches to computer system validation (CSV) are a significant barrier to Digital Transformation and Manufacturing Modernization. The […]
FDA Shares Insights on Digital Transformation & Manufacturing Modernization Read More »
By Daniel R. Matlis Sanmina’s Medical Division manufactures a wide range of products and systems for well known medical OEMs including laboratory, biotechnology, diagnostics, therapeutic,
Sanmina Medical Embraces Cloud MES To Optimize Manufacturing Read More »
Regulatory Consideration for AI-Enabled QMS Life Science companies must adopt Predictive Quality. This eBook, sponsored by Sparta Systems, discusses how industry should leverage FDA’s Good Machine
eBook: AI Drives Shift from Reactive to Predictive Quality Read More »
Dassault Systèmes 3DExperience North America 2019 Forum Event Brief By: Daniel R. Matlis, President At this year’s 3DEXPERIENCE North America Forum, Dassault Systèmes continued to
More Than Skin Deep: Dassault Systèmes is Transforming the Patient Experience Read More »
By Daniel R. Matlis, President “The only certainty is UNCERTAINTY” declared Anton Chilton, QAD’s Chief of Global Field Operations, during his opening remarks at QAD
Thriving in a World Where the Only Certainty is UNCERTAINTY Read More »
By: Tamara Briggs, Process Improvement Analyst History has taught us that the only constant is change, however in today’s industries, the rate of change is
Change is a Constant, Why is it So Challenging… Read More »
Managing the Chain of Custody and Identity for Regenerative Medicine Products. By: Daniel R. Matlis, President According to FDA Commissioner Scott Gottlieb, M.D. “We’re at the beginning of
Lot Size: YOU – When YOU are the RAW MATERIAL and the FINISHED PRODUCT Read More »
By Daniel R. Matlis 2017 has been an exceptional year for Axendia. We were recognized by CIOReview magazine as one of the 20 Most Promising
Award Winning Year for Axendia – Looking at the 2018 Crystal Ball Read More »
By: Daniel R. Matlis Axendia was recently briefed by ComplianceQuest’s executive team. The team, 80% of whom have deep experience in the Enterprise Quality Management
ComplianceQuest Offers Cloud Native Enterprise Quality Management Solutions Read More »
By: Giselle C. Matlis, Research Assistant On August 29, 2017 the FDA published a Safety Communication, Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott’s
FDA confirms: Hacking a pacemaker only requires commercially available equipment Read More »
By: Sandra Rodriguez, Market Analyst and Ellyn McMullin, Research Associate, Axendia Inc. One of the basic tenets of investigative reporting is getting to the facts
WHY Is Data Integrity the Foundation of Good Science? Read More »
From Quantum Mechanics to Population Health Modeling By: Daniel R. Matlis, President “The Holy Grail of Life Science and Healthcare is the development of a
Engineering the Precision Medicine Revolution Read More »
