Category Archives: Uncategorized

14Aug/19
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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  • Why you cannot validate AI with outdated CSV models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.

15Jul/19
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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

14Jun/18
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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.

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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

30Apr/18
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Change is a Constant, Why is it So Challenging…

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 happening at an increasingly, unmanageable rate.  Axendia’s research on the future of change and configuration management revealed that over 50% of industry professionals worry that their current processes are too slow and cumbersome.

Daniel Matlis, President of Axendia, and Mike Jovanis, Vice President of Vault Quality at Veeva Systems, shared their perspectives on the challenges of change management in FDA regulated industries during an FDANews Webinar.  Specifically, they discussed the importance of simplifying change management across the product life cycle.  Topics of discussion included:

  • Change Management Challenges
  • Closed-loop Quality Processes
  • Collaborating on Change Management
  • Moving from Documents to Structured Data
  • Becoming a Proactive Quality Organization
  • Transforming Change Management Programs

Continue reading

27Apr/18
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Lot Size: YOU – When YOU are the RAW MATERIAL and the FINISHED PRODUCT

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 a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.”

The promise of individualized therapies is why the FDA is encouraging and supporting innovation in this field. To this end, the Agency has released a framework outlining how it intends to apply existing laws and regulations to oversee these products. FDA’s stated goal is to ensure that it is nimble and creative to foster innovation, while taking steps to protect the safety of patients.

In individualized patient-derived cellular gene therapy products, the patient is the raw material, product, and the treatment.  In gene therapy products, cells removed from the patient become the raw material.  They are then genetically modified and returned to the patient as the “finished product”.

Continue reading