Category Archives: Business

08Jul/19

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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28Jun/19

Artificial Intelligence Can Make Pharmaceutical Companies More Competitive

Quartic.AI Briefing Note

By: Eric M. Luyer, Industry Research Analyst

Axendia was recently briefed by the senior executive team of Quartic.ai, based in San Jose, CA, US.   Quartic.ai was founded in 2017 by veterans in process automation, manufacturing, and reliability in conjunction with data scientists to optimize the practical use of information through Artificial Intelligence (AI) deployment.  The company had been recognized last year as the fastest growing technology leader in industrial AI by CIO Review Magazine.

The mission of Quartic.ai is to enable subject matter experts (SME) to help solve manufacturing problems by using AI. “We look at this as becoming another tool in their tool-belt of problem-solving. What we’re building enables the SMEs to build their solutions with AI”, said Rajiv Anand the CEO of Quartic.ai.

According to Rajiv Anand, their vision and mandate is not to grow their business through providing services, but by providing the technology. Their technology is a complete “smart industry platform” to support process- and pharma manufacturing industries via digital transformation using the concepts of the Industrial Internet of Things (IIoT) and AI. Continue reading

13Jun/19

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

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

05Mar/19

Disruption is on the Radar! You Must Plot a Course for Success.

Webinar Available On-Demand

Disruption is on the radar! Life-Science executives must plot a course for success.  That was the theme of our “Straight from the Source” webinar featuring Axendia’s President, Daniel R. Matlis and Sandra K. Rodriguez, Market Analyst, on February 20th.

Since 2005, Industry stakeholders and regulators have relied on Axendia for trusted advice on Business, Regulatory and Technology issues and trends.  Due to our track-record of accurately predicting Life-Science trends, our clients often ask us to forecast what’s on the horizon.

To answer this question, we developed a Life Science radar to communicate our focus areas in the markets we service, as well as share when we predict these trends will become mainstream. Continue reading