Category Archives: Business

14Jan/22

Cloud MES is Being Sought After. More Than You Might Think!

Implications of Honeywell Process Solutions Performix Acquisition – Briefing Note

By: Sandra K. Rodriguez, Sr. Industry Analyst

Axendia was recently briefed by Shawn Opatka, Vice President Life-Sciences and Sham Afzalpurkar, GM Life-Sciences at Honeywell Process Solutions.  This business unit is part of Honeywell Performance Materials and Technologies, with over 13,000 global employees and operates in 120+ countries world-wide and has 30 years of experience providing solutions to the Life-Sciences industry.  They include controls and automation, lifecycle services, process measurement and thermal solutions.

Image source: Honeywell

Honeywell and Performix MES

With joint wins and projects in both pharmaceuticals and food & beverage, the acquisition of Performix made sense to Honeywell.  “Performix has been a great partner and the timing was right. We’ve already show great success,” said Opatka.

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16Dec/21

10 Regulatory Commandments of Artificial Intelligence

By: Giselle C. Matlis, Research Assistant

As artificial intelligence (AI) and machine learning (ML) become more popular in the healthcare and medical device industry, their use could irrevocably change the way data is processed and lead to a greater understanding of medical information. Although there are many benefits, this technology could also have unintended consequences.

To this end, FDA along with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada released 10 guiding principles for good machine learning practice for medical device development.

These 10 “commandments” of AI will promote safe, successful, and high caliber use of these tools in the medical device world.

The Ten Regulatory Commandments of AI are:

  1. Thou Shall Ensure That Multi-Disciplinary Expertise Is Leveraged Throughout the Total Product Life Cycle
  2. Thou Shall Ensure That Good Software Engineering and Security Practices Are Implemented
  3. Thou Shall Ensure That Clinical Study Participants and Data Sets Are Representative of the Intended Patient Population
  4. Thou Shall Ensure That Training Data Sets Are Independent of Test Sets
  5. Thou Shall Ensure That Selected Reference Datasets Are Based Upon Best Available Methods
  6. Thou Shall Ensure That Model Design Is Tailored to the Available Data and Reflects the Intended Use of the Device
  7. Thou Shall Ensure That Focus Is Placed on the Performance of the Human-AI Team
  8. Thou Shall Ensure That Testing Demonstrates Device Performance during Clinically Relevant Conditions
  9. Thou Shall Ensure That Users Are Provided Clear, Essential Information
  10. Thou Shall Ensure That Deployed Models Are Monitored for Performance and Re-training Risks are Managed

This collaborative guideline will assist developers in making the right choices when employing these unique technologies in the medical device field. Furthermore, they will encourage the use and growth of these remarkable tools in the medical device world to change it for the better.

11Nov/21

Veeva Enters Operations Execution Domain in the Cloud

Veeva Vault Quality Briefing Note

Axendia was recently briefed by the Executive team at Veeva Vault Quality, Mike Jovanis, Vice President of Vault Quality, Kent Malmros, Senior Director of Vault Training, Jason Boyd, Senior Director of Vault LIMS, and Gagan Bhatia, Director of Product Marketing.

“We are building the industry cloud for Life Sciences,” affirmed Peter Gassner, President and CEO of Veeva during his keynote at the company’s summit in 2018 (See: Veeva is Building the Life Sciences Cloud with High Speed and Velocity)

Since then, Veeva has made significant investments towards that goal. The company built a cloud native QMS solution, made inroads to provide the right content for the right station on the shop floor with Station Manager (see: Samsung Biologics CIO Shares Vision for Modernizing Manufacturing Quality) as well added new offerings in Learning Management (see: Leading Companies Modernize Quality Management in the Cloud).

During this briefing, Veeva’s Management team provided an update on new product offerings, including the LearnAboutGmp (now Veeva LearnGxP) acquisition, the launch of Vault Validation Management application for paperless validation and the company’s entrance into the Operations Execution Domain with the launch of Vault LIMS.

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24Oct/21

3D Printing Capacity Critical in Preparing for a Pandemic

By: Jared N. Matlis, Research Assistant

Preparedness is a skill which is necessary for success in any situation, whether it is a job, schooling, or warfare. So much so that it is immortalized in the Latin phrase Si vis pacem, para bellum, in other words, “if you want peace, prepare for war”. This is a sentiment which the United States knows well, as it has the undisputed best equipped and powerful military in the world.  However, a report from the America Makes <AMCPR> initiative “Assessing the Role of Additive Manufacturing in Support of the U.S. Covid-19 Response”, underwritten by the FDA, depicts how in 2020 the United States was caught unprepared by the invasion of Covid-19.

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04Oct/21

Digital Transformation: The Business Imperative for Life-Sciences

By Daniel R. Matlis, President

“Necessity is the mother of invention,” says the ancient proverb.  In my opinion, the corollary is: “disruption is the matriarch of transformation,” especially for the Life-Sciences industries.

The COVID-19 epidemic has been the biggest global disruption in our generation. It represents a watershed moment for transformation throughout our industry.

Disruption is the new normal. This new paradigm is forcing Life-Science companies to re-imagine the way they operate; transforming and accelerating product development, regulatory review, manufacturing, and distribution cycles aimed at improving patient outcomes.

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