Category Archives: Quality

18Mar/20

COVID-19 Black Swan Colliding with Your Supply Chain?

By: Daniel R. Matlis, President, Axendia, Inc.

Globalization and outsourcing have increased the volume of geographically dispersed partners, facilities, and suppliers in the Life-Science global supply chain. This has resulted in increased supply chain risk and decreased predictability due to variability and complexity and increasing the impact of ‘Black Swan’ events on the healthcare ecosystem.

In 2010 we started preaching about some of the risks associated with globalization, outsourcing and single sourcing in Life-Sciences (See Research Report Achieving Global Supply Chain Visibility, Control & Collaboration in Life‐Sciences: “Regulatory Necessity, Business Imperative”).

While many analysts focused on the rewards of these practices, Axendia took a holistic risk-based approach.

Globalization and Outsourcing allowed the COVID-19 Back Swan to Take the Crown:

In his book “The Black Swan: The impact of the highly improbable,” Nassim Taleb defines a ‘Black Swan’ as an event characterized by rarity, extreme impact, and retrospective (though not prospective) predictability.

Corona (Latin for Crown) is likely the largest Black Swan event to affect the Life-Science supply chain in a generation.

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24Feb/20

eBook: Adopting a Cloud Culture in Support of Quality and Business Outcomes

Executive Accounts of Cloud QMS Success

In the Life-Sciences industry, organizations have implemented on-premises quality management systems (QMS) to support regulatory requirements and replaced paper-based processes for decades. However, these systems were often implemented to mitigate regulatory findings rather than create visibility, traceability and accountability throughout the product lifecycle.

Based on Axendia’s primary research and interviews with executives on the adoption of Cloud QMS in the Life-Sciences, we determined that many companies – large and small – are taking a different course. They are adopting a cloud culture while modernizing processes in support of better quality and business outcomes.

In this voice of the customer eBook, presented by Veeva Systems we review:

  • Getting Comfortable with Cloud
  • Not All Clouds are Created Equal
  • Why Cloud? Why Now?
  • End-to-End QMS Capabilities
  • Pros, Cons and Pitfalls to Avoid

Culture change is imperative to the success of any organization transitioning to the cloud.

Contact our Analyst Team to obtain your personal-use only copy.

10Jan/20

Webinar: Real-Time Operations Intelligence for Life-Sciences

Reduce Validation Efforts Up to 70% 

In this webinar presented jointly by Axendia, Bigfinite, and Honeywell, we will discuss how companies are increasing quality and efficiency by consolidating disparate manufacturing data with new batch visualization, advanced analytics, artificial intelligence and IoT. Learn how new capabilities can offer:

  • Improved process efficiency and yield
  • Predictive quality insights
  • Integrated, real-time visualization
  • Effective troubleshooting
  • Workflow efficiency
  • Reduced validation effort

On February 5, 2020 at 10AM Eastern, we will also discuss how to stay GxP-compliant while reducing documentation and validation efforts by up to 70%, bringing product to market faster.

Meet Your Presenters

Honeywell-Webinar-Speakers

Dan Matlis, President of Axendia, will moderate as industry thought leaders Pep Gubau and Matthias Maaz, illustrate strategies to achieve intuitive process and operational intelligence, improving manufacturing operations in a GxP compliant manner with end-to-end data integrity.

register

08Jan/20

Keeping the Enterprise Connected

AssurX Briefing Note

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by the Executive Management team at AssurX.  With over twenty years of experience in the Life-Science industry, AssurX is helping customers ensure compliance, improve quality and manage risks via the AssurX platform for integrated enterprise tracking.  AssurX software solutions are available on-premises, in the cloud or as a hybrid option.  The AssurX platform is architected so that customers who are on-premise, can (at any time) move to a combination hybrid or pure cloud solution.  “Customers may have some applications in the cloud, and some on-premises, depending on their security parameters, but the system is 100% portable,” pointed out Tracy Orlick, Director of Marketing at AssurX.

The AssurX Integrated Enterprise Tracking Platform Source: AssurX

AssurX seeks to deliver complete solutions based on Life-Science industry customer requirements.  “It’s an ever-changing landscape; there are a lot of regulations and there are foundational things that any Life Science company starts on, like change control, CAPA, etc.,” said Stephanie McArdle, VP Product Management – Life Sciences Industry at AssurX. Continue reading

21Nov/19

Samsung Biologics CIO Shares Vision for Modernizing Manufacturing Quality

By: Daniel R. Matlis, President

Samsung Biologics is a world-class contract development and manufacturing organization (CDMO) located in Songdo, South Korea.

James Choi, VP and CIO, Samsung BioLogics

James Choi, VP & CIO Samsung Biologics

Founded in 2011, Samsung Biologics has the largest total plant cell culture capacity in the world from a single location:  364,000 L.  The company employs more than 2500 employees including 100+ global expats from 12 countries.

To discuss the company’s vision for modernizing manufacturing quality, I sat down with James Choi, VP and CIO, Samsung Biologics, at the 2019 Veeva R&D Summit.

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