Category Archives: Quality

21Nov/19
Samsung Bio Logo

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.

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05Nov/19
Veeva-Summit-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.

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14Aug/19
ebook cover image

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.

08Jul/19
Jumping

Webinar: Digital Transformation Enables Review by Exception at FDI – A Case Study

A Straight from the Source Webinar Available On-Demand

Review by Exception is the ultimate goal of Electronic Batch Records (EBR) and Manufacturing Execution System (MES) implementations at Life-Science organizations. Yet few industry companies have achieved this goal.

Fujirebio Diagnostics Inc., (FDI) is undergoing Digital Transformation, starting with MES / EBR implementation, resulting in a Review by Exception approach for manufacturing batch records.

Join FDI’s Samantha Schloth and Axendia’s Daniel R. Matlis for a live webinar on August 6 at 11:00 AM ET to learn how Digital Transformation is enabling Review by Exception and reducing manufacturing cycle times.

We will discuss:

  • Undergoing Digital Transformation
  • Leveraging FDA’s Risk Based Computer System Assurance Approach
  • An Implementation Strategy for success
  • Moving from Paper to Digital Records
  • The Value of Review by Exception
  • Lessons learned, challenges and opportunities

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Register to view the webinar on-demand.

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01May/19
Living-heart-project

Axendia to Provide Life-Science Analyst Keynote at 3DEXPERIENCE FORUM 2019

Harnessing Positive Disruption in Life Sciences to Achieve Patient-Centric Care

By: Daniel R. Matlis, President

Life-Science organizations must transform or be disrupted! They must harness positive disruption to achieve patient-centric care that supports prevention, improves outcomes as well as providing a holistic patient experience that drives value.

However, to achieve patient-centric care, Life-Science organizations must undergo digital transformation that enables closed loop visibility across the product lifecycle. This transformation requires core paradigm shifts in corporate culture, incentives, strategic planning, regulatory frameworks as well as technological solutions for industry stakeholders.

Male-Anatomy-Background-composite-cropped-low-resNew technologies like modeling and simulation, artificial intelligence and the Internet of Medical Things (IoMT) are enabling patient-centric models to serve more people around the world. The foundation of patient-centric care is the ability to connect the real and digital worlds through multi-discipline, multi-scale modeling and simulation, IoMT connected devices, visibility to data for decision support and greater collaboration. Continue reading