Tag Archives: Axendia

27May/20

Transforming Quality Management with a Modern Cloud Solution

Webinar Available On-Demand

By: Sandra K. Rodriguez, Market Analyst

For decades, life sciences companies have implemented on-premises quality management systems (QMS) to support regulatory requirements and replace paper-based processes. These systems were often implemented to mitigate regulatory findings rather than to create visibility, traceability and accountability throughout the product lifecycle. Today, companies are taking a different course and are adopting a cloud culture to modernize processes, improve supplier collaboration, and drive better quality and business outcomes.

I was recently joined by Joe Vigil, Director Quality Systems at Ultragenyx, and Mike Jovanis, VP Vault Quality at Veeva Systems, to discuss the achieved business benefits of a cloud-based quality solution on a webinar presented by Veeva Systems.

We discussed the internal and external factors that are contributing to the adoption of Cloud QMS and the benefits of an industry cloud platform including time to value and reduced validation efforts.   

With merger and acquisition activities a daily reality in the life sciences industry, companies are growing at rapid rates. “We started our journey to a cloud QMS about three years ago in 2017. At that time, we had about 350 employees and no commercial products. Today we’re over 750 employees and have two commercial products. So, we’ve grown quite a bit in a few years’ time, and we really were looking for a cloud solution that could grow with us,” said Vigil.

Continue reading
04May/20

Technology’s Role in Overcoming a Disrupted Life-Sciences Reality

The Watershed Moment for Modernization and Digital Transformation

By: Daniel R. Matlis, President

Life-Science companies are at the forefront in the fight against COVID-19.  However, many organizations are facing challenges managing their business in the new virtual and remote reality.  The demand for organizational visibility, control and collaboration to achieve resilience is a catalyst to modernization and digital transformation in our industry.

To explore technology’s role in overcoming a disrupted Life-Sciences reality, I was joined by Hugo Felix, Director at Pfizer and Sandra K. Rodriguez, Market Analyst at Axendia in a “Straight from the Source webinar presented by MasterControl.

This Event Brief provides key recommendations on opportunities to leverage technology to:

Continue reading
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.

Continue reading
04Mar/20

Artificial Intelligence and Machine Learning: More Than Just Hype

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.

Continue reading
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.