Category Archives: Quality

10Jan/20

Webinar: Real-Time Operations Intelligence for Life-Sciences

Reduce Validation Efforts Up to 70% 

In this webinar presented jointly by Axendia, Bigfinite, and Honeywell, we will discuss how companies are increasing quality and efficiency by consolidating disparate manufacturing data with new batch visualization, advanced analytics, artificial intelligence and IoT. Learn how new capabilities can offer:

  • Improved process efficiency and yield
  • Predictive quality insights
  • Integrated, real-time visualization
  • Effective troubleshooting
  • Workflow efficiency
  • Reduced validation effort

On February 5, 2020 at 10AM Eastern, we will also discuss how to stay GxP-compliant while reducing documentation and validation efforts by up to 70%, bringing product to market faster.

Meet Your Presenters

Honeywell-Webinar-Speakers

Dan Matlis, President of Axendia, will moderate as industry thought leaders Pep Gubau and Matthias Maaz, illustrate strategies to achieve intuitive process and operational intelligence, improving manufacturing operations in a GxP compliant manner with end-to-end data integrity.

register

08Jan/20

Keeping the Enterprise Connected

AssurX Briefing Note

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by the Executive Management team at AssurX.  With over twenty years of experience in the Life-Science industry, AssurX is helping customers ensure compliance, improve quality and manage risks via the AssurX platform for integrated enterprise tracking.  AssurX software solutions are available on-premises, in the cloud or as a hybrid option.  The AssurX platform is architected so that customers who are on-premise, can (at any time) move to a combination hybrid or pure cloud solution.  “Customers may have some applications in the cloud, and some on-premises, depending on their security parameters, but the system is 100% portable,” pointed out Tracy Orlick, Director of Marketing at AssurX.

The AssurX Integrated Enterprise Tracking Platform Source: AssurX

AssurX seeks to deliver complete solutions based on Life-Science industry customer requirements.  “It’s an ever-changing landscape; there are a lot of regulations and there are foundational things that any Life Science company starts on, like change control, CAPA, etc.,” said Stephanie McArdle, VP Product Management – Life Sciences Industry at AssurX. Continue reading

21Nov/19

Samsung Biologics CIO Shares Vision for Modernizing Manufacturing Quality

By: Daniel R. Matlis, President

Samsung Biologics is a world-class contract development and manufacturing organization (CDMO) located in Songdo, South Korea.

James Choi, VP and CIO, Samsung BioLogics

James Choi, VP & CIO Samsung Biologics

Founded in 2011, Samsung Biologics has the largest total plant cell culture capacity in the world from a single location:  364,000 L.  The company employs more than 2500 employees including 100+ global expats from 12 countries.

To discuss the company’s vision for modernizing manufacturing quality, I sat down with James Choi, VP and CIO, Samsung Biologics, at the 2019 Veeva R&D Summit.

Continue reading

05Nov/19

Transforming Quality, a Top Priority for Customers at Veeva Summit 2019

Veeva Summit 2019 Event Brief

By: Daniel R. Matlis, President

Veeva has become a strategic technology partner to more than 775 customers across the globe, ranging from the world’s largest pharmaceutical companies to emerging biotechs.

Veeva-Summit-Check-In

I had the opportunity to cover the 2019 Veeva R&D Summit in Philadelphia, PA in September.  The event brought together more than 1,700 life science professionals and experts to share the latest market trends in the industry, experience innovative technology, and share best practices. The annual event has experienced 25% attendance growth compared to 2018.

This brief focuses on my first-hand interactions with leading industry executives leveraging Veeva’s quality offerings to modernize quality management in the cloud.

The following executives shared how they are leveraging modern cloud-based solutions to transform quality management:

  • James Choi, VP and CIO at Samsung BioLogics, shares his vision for modernizing manufacturing quality.
  • Chris Lamont, Director, Global QMS Programs at Bristol-Myers Squibb presents the company’s journey to achieve enterprise quality with Vault QMS.
  • Jennifer Trundle, Associate Director, Quality Management Systems at Gilead discusses the successful expansion of Vault QualityDocs across the global enterprise.

Continue reading

14Aug/19

eBook: AI Drives Shift from Reactive to Predictive Quality

Regulatory Consideration for AI-Enabled QMS

Life Science companies must adopt Predictive Quality.  This eBook, sponsored by Sparta Systems, discusses how industry should leverage FDA’s Good Machine Learning Practices (GMLP) to implement AI in order to drive improved productivity and intelligent decision-making while meeting regulatory requirements.

AI EBOOK IMAGE 2“The ability of artificial intelligence and machine learning software to learn from real-world feedback and improve its performance is spurring innovation and leading to the development of novel medical devices,” said Dr. Scott Gottlieb, MD, 23rd Commissioner, US FDA.

The use of AI and ML can enable Life Science organizations to harness data and turn it into intelligent and actionable insights that enable predictive quality. AI systems can process data from point solutions to glean intelligence and  support decision-making.

In this eBook we also discuss:

  • Why you cannot validate AI with outdated CSV models
  • How AI is enabling the shift to predictive quality management
  • Implications for the Life Sciences industry

Register to receive your complimentary copy.