18Mar/20

COVID-19 Black Swan Colliding with Your Supply Chain?

Business, Latest, Quality, Regulatory, Supply Chain, Technology, ,

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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04Mar/20

Artificial Intelligence and Machine Learning: More Than Just Hype

Latest, Technology, , , , ,

Bigfinite Briefing Note

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by the Executive Management team at Bigfinite following their announcements of their Series B funding and news of their collaboration with Honeywell.  With an executive team that has over thirty years of experience in the Life Science industry, Bigfinite helps biotech and pharmaceutical companies establish a lasting, competitive advantage through an agile and effective use of manufacturing data via their GxP-compliant AI/ML SaaS platform. The platform is offered as a single tenant, virtual private cloud for every one of its clients for security and for confidentiality purposes.

“We are not only tech people doing pharma, we are also pharma people doing tech,” began Pep Gubau, CEO at Bigfinite.  Manufacturing intelligence is not new; yet it remains a challenge.  Pharma, as well as other industries, have dedicated a lot of effort and technology towards this initiative for many years. “We believe manufacturing processes can’t be improved due to an incomplete understanding of operational realities.  There are still too many things that contribute to variations in processes that are not well understood. That leads to repeat deviations and the inability to get the root causes of those deviations,” said Claus Abildgren, VP Business Development at Bigfinite.

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24Feb/20

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

Cloud, Latest, Quality, Technology, , ,

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.

04Feb/20

Data Governance: the Foundation for Data Integrity and Digital Transformation

Business, Latest, Regulatory, Technology, , ,

An Axendia Straight from the Source Webinar

Life-Science companies are obsessed with collecting data, retaining and hoarding it to meet statutory and regulatory requirements.

Unfortunately, most companies do not manage these data and as a result are unable to harness it to improve quality, compliance or process efficiency.

A formal data governance program supports the definition, production, and usage of data across its lifecycle to manage risk and improve the quality of data assets.

Join Joseph Ricci from Absolute Integration Inc., and Axendia’s Daniel R. Matlis for a live webinar on 04-March-2020 at 11:00 AM ET to learn how Data Governance is the foundation for data integrity and digital transformation.

We will discuss:

• The business, regulatory and technology benefits of formalizing Data Governance
• Building and formalizing a meaningful and non-invasive program
• Data Governance as a process, not a project
• How to use Data Governance as the foundation for data integrity and digital transformation.

Meet Your Presenters

Can’t make this time? Register and you will be able to watch the On-Demand recording after the event.

10Jan/20

Webinar: Real-Time Operations Intelligence for Life-Sciences

Business, Latest, People, Quality, Regulatory, Technology, ,

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