Category Archives: Business

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

05Jun/18
Quality+IoMT-800x600

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.

22May/18
EU MDR LSP Tile

INFOGRAPHIC: Digital Transformation is a Journey to Support EU MDR and Beyond

Achieve Sustainable, Positive Disruption

By: Sandra K. Rodriguez, Market Analyst

Compliance with Medical Device Regulation 2017/745/EU also commonly referred to as EU MDR, is presenting a significant challenge for the medical device industry. Executives we’ve talked to have stated:

  • “Older products will present a real challenge for us. 20 and 30 years ago, there weren’t many requirements for human factors, clinical trials and risk data”
  • “We are trying to get our business units to think about the systems as a platform….to execute against business processes which can be shared across organizations”

Are you lost? Access our Infographic for a road map to sustainable, positive disruption and see for yourself why Digital Transformation is a journey to EU MDR and beyond.  We’ve identified some road hazards and areas of interest along the way.Digital Transformation EU MDR

With the right platform, meeting the next regulatory requirement becomes an issue of formatting the data… not chasing it down.

Register to receive the Infographic today and keep an eye out for additional information.

09May/18
Magician Palladium

Are Spreadsheet Wizards Doing Data Alchemy to Transform Your Data into Intelligence?

Bigfinite Brings a SaaS Platform that Uses Big Data, Artificial Intelligence (AI) and Machine Learning (ML) to Capture Data in the Cloud via IoT Technologies

By: Daniel R. Matlis, President

Life-Science companies are obsessed with hording documents.  These documents are filled with meaningless data.

Axendia research shows that 85% of companies surveyed rely on document driven processes.

Much of these meaningless data are unstructured, untagged and untapped.  Data are spread across countless repositories. They are saved in PDF documents and spreadsheets, in portals, share drives and email systems, in ERP, QMS, LIMS, MES, and PLM in process control systems and historians, etc.

However, data, even Big Data, on their own are not enough.  What is needed is intelligence.  Intelligence can be applied to answering scientific questions about product or process changes and the potential impact to both the product and the patient.

Unfortunately, many Life Science companies are suffer from DRIPPPP_INATU_CLP_WaterDroplet_B

DATA

RICH

INTELLIGENCE

POOR

Data Alchemy is NOT the Fix for DRIP

Until recently, the challenge has been the ability to turn these vast amounts of meaningless data into actionable intelligence, while supporting compliance with regulatory requirements.

Magician PalladiumHistorically, transforming meaningless data into actionable intelligence required hordes of spreadsheet wizards performing data alchemy. Data alchemists would hoard, compile, purify, distill, and perfect vast amounts of meaningless data and turn it into quasi-actionable intelligence.  Often working with months old data, the job of a data alchemist is tedious, resource intensive and often non-reproducible.

What if you could throw your data into a qualified data lake and use every technology buzzword to transform it into actionable intelligence?

Can Big Data, AI, ML, Cloud and IoT Fix the DRIP?

bigfinite logoAxendia was recently briefed by Bigfinite management to learn how the firm’s platform can address Life Science manufacturing problems that cannot be easily solved with current solutions. Continue reading

04May/18
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WHAT DOES IT TAKE TO WIN AN ERGO CUP®?

THEY SAY IT TAKES A VILLAGE TO RAISE A CHILD, WELL, IT TAKES A VILLAGE OF VOLUNTEERS TO WIN AN ERGO CUP®

By: Mónica V. Matlis, Vice President Ergonomics
2018 Applied Ergonomics Conference ERGO Cup® Competition Co-Chair

Whenever the Applied Ergonomics Conference ends, I leave on a high. Adrenaline is still pumping in my veins. My co-chair, Jeff Hoyle, and I have just finished a “live stream” of the conference award ceremony and announced the winners of the internationally recognized ERGO Cup® competition. After months of preparation, we have finally closed the conference with an excitement that is contagious. We take a few minutes to acknowledge the winners by taking selfies with the teams and thanking them for the months of hard work & preparation.AEC Winning Moment

The internationally recognized Ergo Cup® competition, sponsored by the Ergonomics Center of North Carolina and Edward P. Fitts Department of Industrial and Systems Engineering at North Carolina State University and presented by IISE, provides an exciting opportunity for companies to highlight their successful ergonomic solutions. The general theme across all Ergo Cup® categories is innovation.  Five Ergo Cup® awards are presented annually for outstanding solutions through training, engineering and teamwork.

To be a finalist at the competition is an honor. To win is an achievement of a lifetime! For these teams, it’s like winning an Oscar.

To receive a copy of this complete article, click here.