Category Archives: Regulatory


FDA Debunks Industry Myths on Electronic Batch Records and Review by Exceptions

Automating Electronic Batch Record review is a key benefit of Modernizing Manufacturing Operations. Yet concerns regarding FDA’s acceptance of Review by Exception (RBE) has prevented many companies from achieving this goal.

In this “Straight from the Source” episode, FDA’s Francisco Vicenty debunks industry myths on Electronic Batch Records and Review by Exception.


2021 Forecast for the Life-Sciences Industry

Industry must adapt and overcome current and future disruptive trends on the horizon. To assist in this effort, Axendia revealed the 2021 Life-Sciences Radar.

In this episode of Straight from the Source, Axendia’s President and Founder, Daniel R. Matlis and Sandra K. Rodriguez, Market Analyst discuss how major disruptions in 2020 have accelerated key modernization initiatives to support resilience through the Life-Science value network.  They also address the need for interdependence across these transformational initiatives to overcome business, regulatory, technology and cultural inertia and plot a course to success.


FDA Shares Insights on Digital Transformation & Manufacturing Modernization

The FDA has recognized that current perceptions and approaches to computer system validation (CSV) are a significant barrier to Digital Transformation and Manufacturing Modernization.  The Agency is working swiftly to reverse this trend through the transition to Computer System Assurance (CSA).

In this webinar, FDA’s Francisco Vicenty and Axendia’s Daniel R. Matlis discuss the Agency’s insights on Digital Transformation & Manufacturing Modernization.

Watch this webinar to gain FDA’s perspective on:

Continue reading

Time to Invest in Bio-Pharma PLM

Selerant Briefing Note

By Daniel R. Matlis

The Executive Management team at Selerant recently briefed Axendia on its formula-based product lifecycle management (PLM) solution.

Founded in 1990, and headquartered in Milan, Italy, Selerant offers an AI enhanced PLM+ QMS solution that supports global formulation development, quality and risk management, regulatory compliance, and innovation management across the formulated product industries worldwide.

“Our Mission is to transform Life Sciences with advanced AI driven Product Lifecycle Management solutions, said Jacopo Colombo, President & CTO at Selerant.  “We are building a new generation solution of technology solutions that unlock the power of AI through product life-cycle management to deliver the highest value to our clients by driving revenue growth, operational excellence and reducing risks of our customers,” he added.

PLM for the Formulated Industries

Continue reading

Sanmina Medical Embraces Cloud MES To Optimize Manufacturing

By Daniel R. Matlis

Sanmina’s Medical Division manufactures a wide range of products and systems for well known medical OEMs including laboratory, biotechnology, diagnostics, therapeutic, patient monitoring and surgical equipment.

For 7 years, Sanmina’s Medical Division has embraced Cloud-MES to optimize manufacturing operations and elevate operational performance.  

To gain a deeper understanding of Sanmina’s journey to Cloud-MES, I interviewed Seán Moran, VP of Operations and Plant Manager at Sanmina Ireland and Wellington Giolo, Head of Sales & Strategic Alliances at 42Q. 

In this Straight from the Source webinar, we discussed:

  • Trends Enabling Cloud-MES in Life-Sciences
  • Sanmina Medical Division’s Cloud-MES Journey
  • FDA’s Role Incentivizing SaaS, Cloud and Manufacturing Modernization
  • The Value of Cloud-MES across Business, Technology & Regulatory Dimensions
  • Managing Medical Device Production in The Age of Disruption

This event brief covers key points from our interview as well as audience questions.

Continue reading