Category Archives: Technology

13Jun/19
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7 Reasons Life-Science Companies are Implementing eQMS in the Modern Cloud

ComplianceQuest Briefing Note

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by Prashanth Rajendran, CEO, and Nikki Willett, Chief Strategy Officer, at ComplianceQuest.  The company sees multiple drivers for an up-tick in the adoption of eQMS in the Life Sciences industry, especially on a modern cloud platform:

  • Electronic Quality Management System (eQMS) as a necessity for emerging growth companies
  • Digital transformation (Quality 4.0)
  • Collaborative global regulatory bodies requiring consistent control
  • The services society demanding more managed applications
  • The power of a single platform to meet multiple business needs
  • The role of quality in merger and acquisition activities
  • Operational efficiencies are driving the top line and profitability

Historically, QMS had been targeted at managing quality/compliance documents. The transition that Axendia has noticed in the marketplace is that while companies still require documentation to support quality processes, what is more important is the underlying data that is housed in those documents. Emerging growth companies typically will focus on the product and getting the product approved…and eQMS was not always at the top of the minds of executives.  However, we’re seeing quite a bit of a change in that emerging growth companies are seeing that going electronic as early as possible is a value and an efficiency gain for them, said Willett.

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15May/19
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Supply Chain Visibility: A Regulatory Necessity and Business Imperative

Brand owners are legally responsible for the safety, efficacy and quality of their products

By: Daniel R. Matlis, President

The globalization of life science products has created unique opportunities and demanding challenges for both industry and regulators.

The globalization and outsourcing of life science products began in the late 1990s. At the time, life science companies began to evaluate their core competencies and decided to outsource non-core competency functions. The primary reason for this trend was to lower costs.

Globalization has also opened new markets for life science products worldwide, with emerging economies representing fresh markets. Concurrently, issues with supply chain security became the responsibility of all parties involved in the procurement/sourcing, manufacturing, packaging and distribution of raw materials, intermediates, and final product to deliver safe and effective medicines to customers.

Recommendations for a New Supply Network Paradigm
Supply chain dynamics are prompting life science companies to seek innovative approaches that improve product safety while simultaneously enhancing clinical outcomes, reducing costs and risks, and ensuring regulatory compliance. To attain the sustained benefits of globalization, the life science products ecosystem must implement a new paradigm to manage global supply chains.

770_mainCompanies must implement new strategies while proactively reducing and controlling risks. This calls for changing the business, technology, and regulatory models traditionally used in the industry. The three key components to managing this shift are on-demand visibility, supply network control, and collaboration.

Continue Reading This Article in Medical Product Outsourcing

01May/19
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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

29Apr/19
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Taking 3D Printing to Heart…New Steps in 3D Printing Medical Applications

Is 3D Printing Still a Phenomenon… or Not?

By: Eric M. Luyer, Industry Research Analyst

3D Printing has been used for some time now for printing very specific surgical tools or patient-specific parts to complete full functioning of the human body.  But is 3D Printing still a phenomenon… or not?

In my opinion it is certainly amazing when you see the latest developments and you apply biomedical engineering to 3D Printing.  Specifically, in the medical field there are various use cases adopting this rather futuristic technology – you may now print entire organs for practical surgical use!   I have read that scientists and researchers have successfully printed kidney cells, sheets of cardiac tissue that have something like a heartbeat, and foundations for a human liver.

Other relatively new examples are:  bio-printed stem cells which has been done by the Heriot-Watt University of Edinburgh, Scotland-UK of human skin, that can be used for burn victims, skin cancer patients or other kinds of diseases that affects the skin in a negative way. Scientists have also successfully created tests for 3D Printing artificial bone tissue(!) and the hope is that such tissues may assist in helping with limiting sporting accidents that so many athletes suffer from.  I have also seen that medical researchers and scientists are well on their way to printing an entire human organ. Continue reading

22Apr/19
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FDA is Enabling Innovation and Modernization

By: Thomas O’Connor, Sr. Chemical Engineer, US FDA

FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the Agency’s mission to protect and promote public health. FDA recognizes that continuous manufacturing is an emerging technology that can enable pharmaceutical modernization and deliver potential benefits to both industry and patients. Continuous manufacturing can improve pharmaceutical manufacturing by, for example, using an integrated process with fewer steps and shorter processing times; requiring a smaller equipment footprint; supporting an enhanced development approach (e.g., quality by design (QbD) and use of process analytical technology (PAT) and models); enabling real-time product quality monitoring; and providing flexible operation to allow scale-up, scale-down, and scale-out to accommodate changing supply demands. Continue reading