Category Archives: Latest

24Jul/18
Dassault LS Image

Dassault Targets Life-Sciences with Mind, Body and Soul

2018 Analyst Brief

By: Daniel R. Matlis, President 

At this year’s conference, Dassault Systèmes demonstrated that they are going after Life-Sciences with Mind, Body, and Soul. Under the leadership of Bernard Charlès, Vice Chairman, Chief Executive Officer, the company displays a rare culture focused on long term audacious goals, driven by unbridled passion yet measured by meticulous execution. Charlès has helped instill a culture of ongoing innovation to further consolidate Dassault Systèmes’ scientific capabilities and make science part of the company’s DNA.

According to Charlès, “Dassault is a company with a long term mentality focused on the success of its customers. Dassault is about creating differentiating software that meets the needs of its clients.

Jean Colombel, Vice-President, Life-Sciences at Dassault Systèmes, commented that the company is working to enable innovative patient experiences through an Holistic Patient-Centric strategy.

Daniel R. Matlis, President at Axendia

Daniel R. Matlis, President at Axendia

In this brief, we reveal how Dassault Systèmes is effectively:

  • Going After the Mind: Building on the success of the Living Heart project, Dassault decided to model another “simple” organ, the human brain, the home of the mind.
  • Improving the Body: The 3D Experience platform allows the design and testing of in-silico 3D experiments based on virtual models, informed by real world evidence.
  • Putting its Soul into Health: Digital environments are pushing the bounds of possibility to transform research, science, the pharmaceutical industry, and medicine in general.

Register to read the full event brief.

19Jul/18
Validation - original (1)

At 21, Computer System Validation Comes of Age

Stop Validating Computer Systems to Death!

By: Daniel R. Matlis, President

“FDA emphasizes that manufacturers are responsible for the adequacy of the software used in their devices and activities used to produce devices.  When manufacturers purchase “off-the- shelf” software, they must ensure that it will perform as intended in its chosen application.

FDA has amended the requirement to state, “When computers or automated data processing systems are used as part of production or the quality system,” for clarification. Software used in production or the quality system, whether it be in the designing, manufacturing, distributing, or tracing, must be validated.”[1]

According to FDA’s Francisco (Cisco) Vicenty, Program Manager, Case for Quality, FDA CDRH, the MedTech industry’s high focus on meeting regulatory requirements versus adopting best quality practices has the potential to increase risk to patients.  This compliance-centric approach has resulted in quality issues and has hampered innovation in manufacturing and product development practices.  Additionally this single-mindedness has led to low rates of investment in automation and digital technologies. Continue reading

13Jul/18
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Lucky 13! What’s in a Number?

At Axendia, We Consider 13 More Than a Lucky Number!

We are quickly approaching our 13 Year Anniversary!  Since 2005, we have been providing trusted advice to Life-Science Industry Executives on Business, Regulatory and Technology Matters. It’s more than just luck, our analysts help a diverse set of clients achieve positive disruption through primary research and deep industry experience in a complex and highly regulated Industry.  Not only is our staff passionate about what they do, they average 20 years of Life-Science industry experience.

As a result, Axendia has proudly built long-term relationships across a broad industry ecosystem including:

Life-Science and Healthcare Organizations 68530 Connected Doctor

We provide strategic advice on key initiatives and understand the issues and priorities facing Industry Executives. We architect strategic road-maps to support positive disruption.

Examples include:

Continue reading

14Jun/18
QAD-Explore-2018-1

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.

QAD-Explore-2018-1

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

11Jun/18
TWD platform diagram - Sparta Systems (002)

Sparta Systems Launches TrackWise Digital SaaS Offering

Life Science Companies are Seeing the Value of Moving to a Cloud-based QMS that is Scalable in Support of a Much Needed Digital Transformation in the Industry

By: Sandra K. Rodriguez, Market Analyst

The Sparta Systems management team recently briefed Axendia on the newly unveiled TrackWise Digital cloud quality management system software platform.  The company, founded in 1994, has undergone several key changes as of late such as a recent acquisition by private equity group New Mountain Capital, and new executive leadership in Dana Jones, CEO  and Vinit Doshi, COO who both joined the company earlier this year.

In addition to TrackWise Digital, Sparta still offers the solution it is perhaps best known for – TrackWise, an enterprise QMS platform.  Although it is a traditional on-prem application, Sparta offers extended cloud capabilities such as quality event intake and supplier collaboration by utilizing a hybrid architecture and seamless user experience.

“Sparta Systems has been a leader in quality management software for the pharmaceutical, medical device, consumer product, and discrete manufacturing industries for over decades. In 2016, Sparta acquired cloud QMS platform 123Compliance, and following a two-year period of heavy investment, rebranded the platform as TrackWise Digital to signal that in our view, it is now equal to our legacy TrackWise platform,” said Brandon Henning, Director of Product Management for TrackWise Digital. Continue reading