Category Archives: Regulatory

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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01Sep/21

FDA Reports on The State of Pharmaceutical Quality

Remote Evaluations, Grading Industry on a Curve and Using AI to Predict Site Inspection Scores

By: Axendia Staff

The FDA issued its latest report on the State of Pharmaceutical Quality.  In the report, the Agency describes Pharmaceutical Quality as the ability of the pharmaceutical manufacturing industry to deliver quality drug products to U.S. patients and consumers. In addition, FDA defines quality drug products as those that are safe and effective and free of contamination and defects.  It is worth noting the absence of the word “compliant” in these definitions.

Hidden among Hand Sanitizer recall data were a number of significant developments on FDA’s regulatory approach.

This Brief represents Axendia’s analysis and insights on FDA’s Report on the State of Pharmaceutical Quality.

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