Category Archives: Supply Chain


Did We Predict the Future?

Free White Paper: Balancing the Risks and Rewards of Globalization

By: Sandra K. Rodriguez, Market Analyst

Axendia conducted a research study assessing the opportunities and challenges of Globalization across the Med-Tech ecosystem.

We learned Med-Tech Executives were primary concerned with:

  • Complying with an increasingly complex regulatory environment
  • Ensuring the quality of products and raw materials across the globe
  • Maintaining consistent standards across an extended network of internal sites and external partners

Executives reported the TOP business threat is the changing regulatory environment (65%).

Considering that massive regulatory changes are impacting Med-Tech today, they were correct.  Recent guidance documents include:

  • ISO 13485:2016
  • ISO9001:2017
  • Unique Device Identifier (UDI)
  • EU MDR and EU IVDR
  • Real World Evidence (RWE) challenges

Also significant were risks associated with geopolitical unrest and natural disasters (43%). At the time of the survey, Japan’s earthquake and tsunami were fresh in the memories of industry executives.  More recently, Hurricane Maria quickly gained the attention of the FDA. Within 30 days of the storm making landfall in Puerto Rico, the agency identified 50 types of devices that it deemed critically important.  The agency indicated in a press release that it was particularly concerned about the potential shortage of blood-related devices.   Other current day geopolitical events affecting industry include Brexit, tensions on the Korean peninsula, and NAFTA re-negotiations that are far from being completed. Continue reading

veeva logo

Modernizing Quality Management with Veeva Vault QMS

Veeva Systems Analyst Brief

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by Mike Jovanis, vice president of Vault Quality at Veeva Systems.  Veeva Systems ( is a cloud computing company focused on the pharmaceutical and life sciences industry.

Veeva Vault Quality customers – companies who own Veeva Vault QualityDocs or Vault QMS – continue to increase in numbers and now include five of the top 20 largest pharmaceutical companies. Launched just a little over a year ago, more than 40 companies have selected Vault QMS ­— and is quickly displacing its competitors.

Historically, quality management solutions have been implemented in a reactionary manner, were on premise, and required extensive configuration to meet user requirements.  “The success of Vault QMS rests on the fact that we are committed to providing best practices, not just infinite configurability,” said Jovanis.  “The true value in using the Vault Quality Suite of applications is that they support end-to-end processes across functional areas and internal and external stakeholders for greater visibility and control,” he added. Continue reading

2017 Year end review

Award Winning Year for Axendia – Looking at the 2018 Crystal Ball

By Daniel R. Matlis

2017 has been an exceptional year for Axendia.  We were recognized by CIOReview magazine as one of the 20 Most Promising Pharma and Life Sciences Solution Providers.  We also had the opportunity to address audiences around the globe, including Asia, Europe, North and South America.

Our analysts had the privilege to provide insight and trusted advice to leaders across the Life Science and Healthcare ecosystems including executives in industry, technology & service providers as well as policy makers and regulators.
In the last year we advised our clients on critical topics such as:


Two Black Swans, One Devastated Region

A Hurricane Named Maria 

By:  Sandra K. Rodriguez, Market Analyst

Disclaimer:  Being based in Puerto Rico, I lived through Irma and Maria; however best practices recommendations apply to anywhere in the world that may suffer a catastrophic event.

A black swan event is one that is extremely rare and unlikely.  Hurricane Irma stormed through the Caribbean on September 6, 2017.  Two weeks later, on September 20, 2017, Hurricane Maria made landfall in Puerto Rico and collided with the supply chains of leading life science companies who have a manufacturing presence on the island.

Scott Gottlieb, M.D., Commissioner of the FDA, took notice immediately and issued a press release within five days to address how the agency would help the island recover and what steps should be taken to avoid critical drug supply shortages for US citizens residing on the island and the US mainland.  Gottlieb wrote, “News coverage has touched on an issue about which we at FDA are very concerned and we are working around the clock to address – the potential for shortages of critical life-saving and life-sustaining drugs needed by patients on and off the island.” Continue reading

Supply-Chain-Squares (3)

Quality Management Across Your Global Supply Chain

By: Sandra K. Rodriguez, Market Analyst

Learn How to Take Back Control of Quality – On Demand Webinar

Daniel Matlis, President of Axendia and Ashley Wentworth, Vaulty Quality Strategy at Veeva Systems presented thought leadership on this topic in an FDANews Webinar on March 22, 2017.  Specifically, they discussed the importance of quality management across the global supply chain in FDA Regulated environments.  Topics of discussion included:

  • Globalization and Outsourcing Trends in Life-Sciences
  • Regulatory Expectations for Outsourcing
  • Quality Metrics and Data Integrity
  • The Paradigm Shift in Quality Management
  • How to Source Quality Data and Benefits of a Cloud QMS
  • Modernizing Quality Management
  • Moving to Predictive Quality Organizations

Globalization and outsourcing has created unique opportunities and demanding challenges for the industry and regulators alike.  Read More.

The webinar is also available on demand.