All posts by Administrator

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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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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16Aug/21

Innovating to Help Industries Transform

Event Brief – SAP Industry Analyst Base Camp 2021

By: Sandra K. Rodriguez, Senior Industry Analyst

Peter Maier, President, SAP Industries and Customer Advisory, opened the 2021 Industry Analyst Base Camp with words of caution, “there is still less consensus about the new normal and the future will be more dynamic and uncertain.” With a variety of industry cloud solutions ranging from Automotive, Banking, Consumer Products, Financial Services to Life Sciences and more, Maier said with confidence, “we are the market maker, once again.”

Recognizing that all companies have different starting points, SAP customers are optimizing existing systems and taking a multi-step approach to transition to a modular cloud architecture.  “Moving to the cloud is a journey, not a destination” added Julia White, Chief Marketing and Solutions Officer and Executive Board Member at SAP.  This architecture is comprised of SAP S/4HANA Cloud, Industry Cloud (3rd Party Apps and SAP), SAP Line-of-Business (LOB) Solutions and the SAP Business Technology Platform (BTP) which brings together enterprise applications into one platform for both cloud and hybrid environments. This includes hundreds of pre-built integrations for SAP and third-party applications. White accurately pointed out that many companies have relied on on-prem technologies for decades.  As a result, there are multiple paths customers can take to make the transition. It is not a one size fits all journey.

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05Aug/21

Digital Integration with PLM: A Fresenius Medical Care Success Story

By: Sandra K. Rodriguez, Senior Industry Analyst

Bill D’Innocenzo, SVP Digital Integration and Larry Dube, VP PLM Digital Strategy at Fresenius Medical Care share the secrets to their successful digital integration journey in this open and frank conversation.

We discuss:

  • How long does it take to build a strong foundation to implement a successful digital integration strategy?
  • Does culture change matter when shifting the mindset of your peers?
  • Who has the best in class, end-to-end solution to meet the needs and requirements of medical device companies who are embarking on their digital journey?

Take a sneak peak of our candid discussion in this video clip:

There’s much more! Watch this “Straight from the Source” webinar now.