Category Archives: Uncategorized


FDA Shares Insights on Digital Transformation & Manufacturing Modernization

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 Agency is working swiftly to reverse this trend through the transition to Computer System Assurance (CSA).

In this webinar, FDA’s Francisco Vicenty and Axendia’s Daniel R. Matlis discuss the Agency’s insights on Digital Transformation & Manufacturing Modernization.

Watch this webinar to gain FDA’s perspective on:

Continue reading

Sanmina Medical Embraces Cloud MES To Optimize Manufacturing

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, patient monitoring and surgical equipment.

For 7 years, Sanmina’s Medical Division has embraced Cloud-MES to optimize manufacturing operations and elevate operational performance.  

To gain a deeper understanding of Sanmina’s journey to Cloud-MES, I interviewed Seán Moran, VP of Operations and Plant Manager at Sanmina Ireland and Wellington Giolo, Head of Sales & Strategic Alliances at 42Q. 

In this Straight from the Source webinar, we discussed:

  • Trends Enabling Cloud-MES in Life-Sciences
  • Sanmina Medical Division’s Cloud-MES Journey
  • FDA’s Role Incentivizing SaaS, Cloud and Manufacturing Modernization
  • The Value of Cloud-MES across Business, Technology & Regulatory Dimensions
  • Managing Medical Device Production in The Age of Disruption

This event brief covers key points from our interview as well as audience questions.

Continue reading

eBook: AI Drives Shift from Reactive to Predictive Quality

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 Learning Practices (GMLP) to implement AI in order to drive improved productivity and intelligent decision-making while meeting regulatory requirements.

AI EBOOK IMAGE 2“The ability of artificial intelligence and machine learning software to learn from real-world feedback and improve its performance is spurring innovation and leading to the development of novel medical devices,” said Dr. Scott Gottlieb, MD, 23rd Commissioner, US FDA.

The use of AI and ML can enable Life Science organizations to harness data and turn it into intelligent and actionable insights that enable predictive quality. AI systems can process data from point solutions to glean intelligence and  support decision-making.

In this eBook we also discuss:

  • Why you cannot validate AI with outdated CSV models
  • How AI is enabling the shift to predictive quality management
  • Implications for the Life Sciences industry

Register to receive your complimentary copy.


More Than Skin Deep: Dassault Systèmes is Transforming the Patient Experience

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 demonstrate its commitment to transforming the patient experience.

Under the leadership of Bernard Charlès, Vice Chairman, Chief Executive Officer, the company continues to substantially deliver on the promise: “to enable innovative patient experiences through a Holistic Patient-Centric strategy.”  (Read:  Dassault Targets Life-Sciences with Mind, Body and Soul)

According to Charlès there are several concurrent themes that are impacting the Life Science industry with Bioscience playing a major role.

  • Healthcare is expensive
  • Healthcare needs to be more inclusive
  • Life-Science product development needs to take advantage of technological changes

“Dassault Systèmes is investing massively in Life Sciences to transform the patient experience with a culture of sustainable innovation and the use of cutting edge technology,” added Charles. Continue reading


Thriving in a World Where the Only Certainty is UNCERTAINTY

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 Explore 2018 in Dallas last month.

“The pace of change is accelerating and if you can’t keep up, you’ll struggle to survive,” said Carter Lloyds, QAD’s Chief Marketing Officer.


To keep up with the accelerating rate of change and cope with uncertainty, organizations must become an “agile and effective enterprise” was a key theme at QAD Explore 2018.

Continue reading