Category Archives: Latest

03Jun/20

Where Does Your Organization Fall on the Cloud Comfortable Scale?

By: Sandra K. Rodriguez, Market Analyst

Based on our conversations with Life-Science executives and quantitative research, it is clear that many companies fall into one of four categories:

  • Cloud Averse
  • Cloud Curious
  • Cloud Comfortable
  • Cloud First

While many companies are uncomfortable with change, a significant portion of the lndustry is developing a digital transformation/integration strategy and becoming cloud curious.  

With many GxP applications already available in the cloud, the cloud comfortable and cloud first companies are more resilient and better equipped to overcome current and future business, technology and regulatory challenges.  These companies are also lowering the compliance costs with multi-site cloud native GxP solutions.

Request your copy of our Cloud Comfortable Scale to determine which category you fall into.  Need more information? We’re here to help!

28May/20

Medical Device Development Cannot Be Managed With Documents

Jama Connect for Medical Device Development Briefing Note

By Daniel R. Matlis

The Jama Software executive team recently briefed Axendia on its new Jama Connect for Medical Device Development platform.   The new solution is designed to help engineering teams manage medical device requirements, risk and design control in a single platform. The medical device offering also aims to make regulatory submissions and audit preparations a straightforward process, speeding time-to-market deployment while supporting device quality.

“We’re excited to introduce our new solution designed specifically for medical device developers which,  will help ease the development process from the start,” said Josh Turpen, Chief Product Officer at Jama Software.  “Jama Connect allows developers to hit the ground running with preconfigured templates and best practices built-in, saving engineering teams from the cumbersome and often frustrating process of filing paperwork,” he added.

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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.

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14May/20

Product Success Platform

Propel Briefing Note

By: Daniel R. Matlis

Axendia was recently briefed by the Executive Management team at Propel following the launch of their Healthcare Manufacturer Community.   Propel is offering its technology and supplier community to accelerate the production of ventilators based on Medtronic’s PB560 open source design. Visit Propel’s Healthcare Manufacturer Community for additional details.

Founded in 2015, and headquartered in Santa Clara, CA, Propel provides a cloud-based product success platform that connects the people, systems and processes needed to deliver products from concept to customer.

Entirely built on Salesforce’s modern cloud, multi-tenant cloud SaaS architecture, Propel allows organizations to take advantage of a modern cloud native product success management solution.

“Propel was founded with the knowledge that a single platform for all product needs allows for greater collaboration, faster decision making and easy deployment. Building on Salesforce allows us to easily integrate the customer and product records on a single platform,” said Ray Hein, CEO & Co-founder.

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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:

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