Category Archives: Technology

24Feb/20

eBook: Adopting a Cloud Culture in Support of Quality and Business Outcomes

Executive Accounts of Cloud QMS Success

In the Life-Sciences industry, organizations have implemented on-premises quality management systems (QMS) to support regulatory requirements and replaced paper-based processes for decades. However, these systems were often implemented to mitigate regulatory findings rather than create visibility, traceability and accountability throughout the product lifecycle.

Based on Axendia’s primary research and interviews with executives on the adoption of Cloud QMS in the Life-Sciences, we determined that many companies – large and small – are taking a different course. They are adopting a cloud culture while modernizing processes in support of better quality and business outcomes.

In this voice of the customer eBook, presented by Veeva Systems we review:

  • Getting Comfortable with Cloud
  • Not All Clouds are Created Equal
  • Why Cloud? Why Now?
  • End-to-End QMS Capabilities
  • Pros, Cons and Pitfalls to Avoid

Culture change is imperative to the success of any organization transitioning to the cloud.

Contact our Analyst Team to obtain your personal-use only copy.

04Feb/20

Data Governance: the Foundation for Data Integrity and Digital Transformation

An Axendia Straight from the Source Webinar

Life-Science companies are obsessed with collecting data, retaining and hoarding it to meet statutory and regulatory requirements.

Unfortunately, most companies do not manage these data and as a result are unable to harness it to improve quality, compliance or process efficiency.

A formal data governance program supports the definition, production, and usage of data across its lifecycle to manage risk and improve the quality of data assets.

Join Joseph Ricci from Absolute Integration Inc., and Axendia’s Daniel R. Matlis for a live webinar on 04-March-2020 at 11:00 AM ET to learn how Data Governance is the foundation for data integrity and digital transformation.

We will discuss:

• The business, regulatory and technology benefits of formalizing Data Governance
• Building and formalizing a meaningful and non-invasive program
• Data Governance as a process, not a project
• How to use Data Governance as the foundation for data integrity and digital transformation.

Meet Your Presenters

Can’t make this time? Register and you will be able to watch the On-Demand recording after the event.

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

09Jan/20

GxP Ready No-Code PaaS IoT Self-Serve Manufacturing Apps

Tulip Interfaces Briefing Note

By: Daniel R. Matlis, President

I recently had the opportunity to visit Tulip Interfaces, Inc., HQ in Somerville, MA to see firsthand how the company is enabling manufacturers to develop digital manufacturing applications with their no-code platform-as-a-service (PaaS) in GxP environments.

Founded in 2012 as a spin-off resulting from more than 10 years of research at the MIT Media Lab, Tulip is a leader in self-serve manufacturing apps. Tulip offers web-based, no-code off-the-shelf, plug-and-play, self-service apps that drive “Rapid Time to Value”.

“We complete the last mile of shop floor automation by giving manufacturing engineers self-service tools to turn every station into an instrumented, data collecting, guided environment— enabling continuous improvement, “said Natan Linder, Founder and CEO of Tulip.

Some of the world’s innovative Life-Science manufacturers are currently using Tulip’s no-code Manufacturing App platform to increase the productivity, quality, and efficiency of their operations, as well as to streamline compliance.

What is a No-Code PaaS IoT Self-Serve Manufacturing App Platform? Continue reading

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