Category Archives: Technology

30Sep/19

Quality Can Only Improve… IF We Allow the Information to Focus on Providing Quality Products

MasterControl Briefing Note

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by the Executive Team at MasterControl.   The company’s mission is to make life changing products available to more people sooner.   One way MasterControl is setting out to achieve its mission, is by enabling its Life-Science customers to obtain what it calls Product Lifecycle Excellence (PLx).  With over 650,000 users spanning more than fifty countries, MasterControl is well positioned to bring a much needed correlation between Product Lifecycle Management (PLM) and Quality Management to the Life-Science industry.

The Need to Connect Decision Loops

Companies typically have quality data spread all over the organization.   Paper-driven production processes on the shop floor are also still a reality in many companies.  These pockets of quality data, when consolidated, have the potential to offer valuable insights to product quality data across the entire lifecycle.  With PLx, MasterControl is seeking to close the gap in the digitalization of the manufacturing environment.   “We looked at how to build an application that is easy for operators to adopt and use, easy for manufacturing environments to deploy and connect to their other systems.  And, in the process, completely eliminate paper off of the shop floor,” said Matt Lowe, Executive Vice President at MasterControl.

Another reality is that although advances in PLM and Manufacturing Execution Systems (MES) have been rolled out over decades, QMS data is often siloed and paper still exists on the shop floor.  The result is a disconnect in information that may range from clinical study quality issues to poor shop floor data integrity.  Additionally, complaint data is often times not looped back into the organizations’ overall quality system.   “Being able to launch quality incidents from the shop floor, enforce training and fill the gap between ERP, MES and LIMS allows companies to achieve next level digital manufacturing excellence and that’s what we’re pursuing,” said Terrance Holbrook, Director of Product Management. Continue reading

05Sep/19

Partnering with Customers to Make Digital Quality a Reality

Sparta Connection 2019 Event Brief

By: Daniel R. Matlis, President

The theme at this year’s Sparta Connection was: “Making Digital Quality a Reality.” Under the leadership of Dana Jones, CEO of Sparta Systems, the company continues to focus on customer success by delivering on commitments, ensuring transparency, and building relationships to earn customer trust.

“We’re 100% committed to putting customers at the center of everything we do, and to partnering with them to accelerate their transformation to digital quality,” said Ms. Jones. “We’re also committed to giving our customers maximum freedom, flexibility and choice by providing a range of options with our cloud, on-premise and hybrid options.”

Sparta Blog Image

To support its commitment to provide flexibility, freedom and choice to deliver quality based on customer needs, Sparta is investing across 3 dimensions:

  • TrackWise® QMS – Sparta announced their continued commitment to the TrackWise on-premise product for existing customers. They also announced that the next version of the product, TrackWise 10, will be coming out in 2020.
  • TrackWise hybrid solution – TrackWise customers can expand the functionality of their existing on-premise instances by seamlessly adding TrackWise Digital cloud modules to TrackWise. This includes cloud modules such as Complaints, Intake and Supplier Quality Management.
  • TrackWise DigitalSM – over 120 customer have selected TrackWise Digital

Continue reading

05Sep/19

Can Digital Evidence Replace Clinical Evidence?

A Straight from the Source Webinar Available On-Demand

FDA is encouraging the use of “Digital Evidence” to inform clinical trial design, predict clinical outcomes, support demonstration of safety and effectiveness, identify relevant patient populations, and support regulatory submissions. 

Digital evidence from in silico clinical trials have been shown to produce similar results as human clinical trials and under certain circumstances may replace clinical evidence. 

Join FDA’s Tina M. Morrison and Axendia’s Daniel R. Matlis for a live webinar on 18 SEP 2019 at 11:00 AM ET. 

We will discuss FDA’s perspective on: 

  • Shifting from traditional evidence sources to digital evidence  
  • How to create virtual patients with digital evidence to replace clinical evidence  
  • Examples of digital evidence in Pharma and Medical Devices used at FDA to initiate and augment clinical studies 
  • Creating an in silico clinical trial playbook
  • Why data in PDF’s are not sufficient 

Meet Your Trusted Sources

Tina and Dan for CC

Register to view this webinar on-demand.

register

14Aug/19

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.

25Jul/19

Medidata: The Missing Link in Dassault Systèmes Powerful Portfolio to Support the Life-Science Industry

Dassault Systèmes Analyst Conference Brief 2019

By: Sandra K. Rodriguez, Market Analyst

The news out of this years’ Dassault Systèmes Analyst Conference was huge: a $5.8 Billion merger offer with clinical data giant, Medidata.  We received the news while traveling from our hotel to the Dassault Systèmes headquarters, nestled in Vélizy-Villacoublay, France.  Aside from the size of the deal – the largest in the history of Dassault Systèmes – Medidata was the missing link in its powerful portfolio to support the Life-Science industry.

Bernard Charlès, CEO and vice-chairman of the board of directors at Dassault Systèmes, opened the two-day meeting with, “To do ‘smart’ anything, you need to know the environment.  The platform phenomenon is not an IT topic… it’s a new way for companies to work.”  Dassault Systèmes now has 250,000 customers, with 25 million users in 140 countries.  The 3DEXPERIENCE platform currently consists of 11 brands/applications that support the ability for people and businesses to develop, collaborate and build products and services in both the virtual and real worlds.

Dassault Systèmes considers itself a Scientific company, first and foremost.   The Industry Renaissance theme of this years’ conference was explained in simple terms by Morgan Zimmermann, CEO for NETVIBES-EXALEAD (the Dassault Systèmes solution for turning large amounts of information into intelligence).  “Think of Renaissance as the new book. The book changed how we distributed knowledge; Industry Renaissance for Dassault Systèmes is the usage of experience as a new way to distribute knowledge and know-how” explained Zimmermann.

The 3DEXPERIENCE Platform offers both people and businesses, virtual universes to imagine, develop and collaborate using innovative solutions.

Life is the New Work Bench

Mentioned earlier in this brief, Medidata was the missing link in the Dassault Systèmes solution platform to support end-to-end product development in the Life-Sciences.  “Pharmaceutical and Biotech companies require roughly ten to twelve years in the R&D phase to bring a drug or therapy to market” explained Claire Biot, Ph.D., VP of Life Sciences Industry at Dassault Systèmes.  Therefore, shifting that timeline left early on in the clinical trial phase of a product adds significant value to Life-Sciences companies.

Image Courtesy of Dassault Systèmes

Image Courtesy of Dassault Systèmes – Claire Bisot.

Clinical trials are necessary to prove the safety and efficacy of a drug on not only a patient population, but the medical condition itself.

Download and read the entire Briefing Note.