Category Archives: Technology

02Jun/21

Leading Companies Modernize Quality Management in the Cloud

Veeva Briefing Note

By: Sandra K. Rodriguez, Sr. Industry Analyst

Axendia was recently briefed by Mike Jovanis, vice president of Vault Quality and Kent Malmros, senior director of Vault Training at Veeva Systems.  Veeva Systems (www.veeva.com) is a cloud computing company focused on the pharmaceutical and life sciences industry.

Veeva Vault Quality customers continue to increase in numbers and now include 14 of the top 20 largest pharmaceutical companies. Leading companies around the world are adopting a cloud culture to lower the cost of implementation and ownership, enable collaboration with external partners, and simplify business processes.  To date, more than 175 biopharma, contract manufacturers, generics, and medtech companies, have adopted Vault QMS to streamline and automate quality processes. “As a trusted partner, Veeva has been collaborating closely with life sciences companies globally on their digital quality initiatives,” said Mike Jovanis, vice president, Veeva Vault Quality. “We are committed to customer success and will continue to deliver customer-focused innovation across product development and manufacturing.”

Vault QMS is part of the Veeva Vault Quality Suite, including Vault Product Surveillance, Vault QualityDocs, Vault Station Manager, and Vault Training to automate and harmonize quality processes globally.

Veeva’s continuous innovation is helping customers proactively manage quality and increase agility. Over the last year, new features for Vault QMS include:

  • Seamless connection between Vault QMS and Veeva Vault Registrations to reduce cycle time and increase transparency within post-market change control
  • Quality Risk Management (QRM) advancements, including FMEA methodology to support proactive identification and mitigation of risks
  • Fully automated process for external auditees such as CMOs and suppliers to respond to audit findings directly within the system
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28May/21

AI-Assisted Automated Visual Inspection: An Amgen Success Story

By: Sandra K. Rodriguez, Senior Industry Analyst

The team at Amgen’s Juncos, Puerto Rico facility successfully implemented and validated the first AI-enabled visual inspection system in a production line. Hear directly from Amgen’s Jorge Delgado, Process Development Scientific Director and Manuel Soto, Senior Process Development Scientist.

We discuss the differences between AI, Machine Learning and Deep Learning, as well as demonstrating proof of concept and implementing the technology in a GMP environment.

Hear the incredible benefits achieved and much more in this “Straight from the Source” webinar.

20May/21

Reinventing the Value Network with the Factory of the Future

The factory of the future goes beyond the traditional factory walls

By: Sandra K. Rodriguez, Senior Industry Analyst

The need for organizational visibility, control, and resilience has never been greater for the life sciences industry. Executives at forward-thinking companies are addressing the need to solve both present and future challenges. The increasing complexity of designing, sourcing, and manufacturing high-quality medical products under stringent regulations requires a digital factory that supports closed loop manufacturing across-the-product lifecycle. In short, a sustainable factory of the future is needed now.

The factory of the future goes beyond traditional factory walls; it requires digital transformation across the entire medical product value network. Axendia research indicates that 76 percent of digital transformation initiatives are being accelerated by “black swan” events. Digital transformation is a journey, not a project. Life science organizations that have embarked on this journey are modernizing manufacturing and reinventing their value networks.

Building the Factory of The Future, Today

Delivering high-quality, next-generation life-science products is not easy. Stakeholders expect high-quality, complex products manufactured sustainably under stringent regulations. The factory of the future supports closed loop manufacturing and workforce optimization by connecting the following technologies across the total product lifecycle:

  • Product Lifecycle Management
  • Enterprise Resource Planning
  • Manufacturing Operations Management (MOM)
  • Advanced Planning and Scheduling (APS)
  • Modeling and Simulation

Read the entire article in Medical Product Outsourcing

Register to receive your complimentary copy of our Voice of the Customer eBook, presented by Dassault Systèmes: The Life-Science Factory of the Future

Webinar available on-demand: Building the Factory of the Future, Today

14May/21

FDA Guidance on ICH Q12 Will Accelerate BioPharma PLM Adoption

As Bio-Pharmaceutical companies look for opportunities to accelerate innovation cycles, the management of products across the complete lifecycle to support continuous improvement is a strategic imperative.  To fast-track innovation, companies need to be open to new ideas and have awareness of new and emerging systems and technologies. 

This week, FDA issued guidance supporting the use of ICH Q12 to encourage the use of Product Lifecycle Management across the Pharmaceutical.

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13May/21

Driving Digital Transformation in a Connected Eco-System

Life-Science companies of all sizes are digitally transforming to improve quality, from raw material to patient, while achieving resilience, effectiveness & efficiency.

Hear from Edward Armstrong, Director QA at Mustang Bio, Beth Hayes, VP, BioPharma Strategy at Salesforce, Prashanth Rajendran, CEO at ComplianceQuest and Daniel R. Matlis, President at Axendia in this panel discussion

Take a sneak peak of our candid discussion in this video clip:

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