Category Archives: Regulatory


Pfizer Uses Positive Disruption to Manage Product Design Across the Lifecycle

COVID-19 forced Life-Science companies to reimagine the way they operate. Pfizer has adapted its Culture, Systems and Processes to drive increased visibility, control and collaboration that have achieved unprecedented results.

Join Pfizer’s Hugo Felix and Axendia’s Daniel R. Matlis for a “Straight from the Source” live webinar on 21-APR-2021 at 11:30 AM ET as they discuss how Pfizer is using Positive Disruption to manage product design across the lifecycle.


Improving Product Quality & Patient Outcomes with Integrated QRM

An Axendia Insight Brief, Presented by Sparta Systems

An effective Quality and Risk Management program enables Life Science manufacturers to proactively manage product quality and patient safety. Risk management is a top priority for regulators around the world with a special focus on combination products and medical devices.

Through the use of an integrated Quality and Risk Management approach, manufacturers can achieve maximum value from their Risk Management program by deeply integrating it to their Quality Management System. In doing so, Life Science manufacturers can unlock process efficiency and enhanced signal and trend detection, leading to improved product quality and reduced patient risk. 

This Insight Brief, presented by Sparta Systems, delves into key points of an integrated Quality Risk Management solution where the ultimate result is improved safety and product quality, driving better outcomes.

To learn how an integrated Quality and Risk Management program can maximize the use of QMS data supporting enhanced Risk Management and mitigation and improved product quality that delivers the maximum benefit to the patient, register to request your copy below.


Digital Transformation Builds Trust Across the Value Network

Disruptions have eroded trust across Life-Science supply chains forcing brand owners to re-evaluate outsourcing programs in favor of Smart-Sourcing strategies that focus on quality, resilience, and value, instead of cost.

As a result, innovative CMOs, like Ori Biotech and SteriPack, are modernizing and digitally transforming their manufacturing operations to support Quality Metrics, Review by Exception and Smart-Sourcing.  

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Improving Process Understanding Across the Product Lifecycle

QbDVision Briefing Note

By Daniel R. Matlis

The Executive Management team at CherryCircle Software recently briefed Axendia on QbDVision®, its cloud-based Product Quality and Lifecycle Management platform integrating product, process, and quality management for Bio-Pharma.

Started in 2017, and headquartered in Austin, TX, the company was founded by Yash Sabharwal, Ph.D., former Co-founder & COO of Xeris Pharmaceuticals and Ryan Shillington, a seasoned software CTO.

“Our mission is to help our customers accelerate therapies to patients by deploying the latest digital and automation technologies which reduce the time and cost of product development without sacrificing product quality,” said Sabharwal.

Built on ICH Pharmaceutical Product Lifecycle Management Guidelines

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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.