19Jul/18
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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
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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.

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
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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

05Jun/18
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New Research: The Impact of the Internet of Medical Things (IoMT) on Patient Outcomes

Axendia conducted a research study focusing on the medical device industry’s ability to build a Culture of Innovation and Quality and we sought to understand the Impact of the Internet of Medical Things (IoMT) on Patient Outcomes and how IoMT is changing the business of healthcare.

We successfully identified and analyzed trends, requirements and initiatives organizations are undertaking to proactively manage products and platforms across the product lifecycle.
In addition to our latest e-Book, we also developed an Infographic.

 

Request your copy now and learn:

  • How the medical device business will change over the next five years as a result of IoT initiatives
  • The biggest challenges companies face when bringing smart, connected devices to market
  • The biggest patient benefits of smart, connected devices
  • What type of medical device companies see IoMT as the biggest business disruptor

In support of the research, we surveyed 110 medical device professionals representing 59 medical device manufacturers from 12 countries, and engaged in one-on-one interviews and group discussions with industry thought leaders.