Category Archives: Cloud

15Nov/18
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See Who’s Soaring to the Cloud in Support of Quality and Compliance

Companies Are Taking a Cloud-First Approach

By: Daniel R. Matlis, President and Sandra K. Rodriguez, Market Analyst

Life-Science organizations have implemented on premise electronic Quality Management Systems (QMS) for decades to support regulatory requirements and replace paper-based processes. These systems were often implemented to mitigate regulatory findings and in response to the “Whack-a-Mole” relationship between Industry and Regulators.

WHACK A MOLE

As a result, many companies implemented “Paper on Glass”, simply duplicating existing paper quality processes in electronic QMS. This approach created an environment of a mixed bag of disparate eQMS installations throughout the enterprise that have high degrees of customization. Now, IT and quality teams are faced with the daunting challenge of upgrading, migrating, and validating outdated legacy on premise QMS systems.

However, based on Axendia’s primary research on the adoption of Cloud QMS in the Life-Science Industry, we quickly determined that companies large and small, are taking a different course and are soaring to the modern cloud.

Our latest Voice of the Customer Report highlights interviews with 10 industry executives and represents 3 innovative Cloud QMS vendors.  This comprehensive reports outlines:

  • Why Cloud is No Longer Taboo
  • Clouds Come in Many Shapes and Sizes – Not All Clouds are Created Equal
  • Executive Accounts of Cloud QMS
  • Why Life-Science Companies Are Moving to the Cloud
  • End-To-End Cloud QMS Capabilities
  • The Pros, Cons and Pitfalls to Avoid
  • Recommendations and Thoughts to Consider

You are welcome to download your complimentary preview here.

To request the full report, please contact: Axendia Research.

14Jun/18
QAD-Explore-2018-1

Thriving in a World Where the Only Certainty is UNCERTAINTY

By Daniel R. Matlis, President

“The only certainty is UNCERTAINTY” declared Anton Chilton, QAD’s Chief of Global Field Operations, during his opening remarks at QAD Explore 2018 in Dallas last month.

“The pace of change is accelerating and if you can’t keep up, you’ll struggle to survive,” said Carter Lloyds, QAD’s Chief Marketing Officer.

QAD-Explore-2018-1

To keep up with the accelerating rate of change and cope with uncertainty, organizations must become an “agile and effective enterprise” was a key theme at QAD Explore 2018.

Continue reading

11Jun/18
TWD platform diagram - Sparta Systems (002)

Sparta Systems Launches TrackWise Digital SaaS Offering

Life Science Companies are Seeing the Value of Moving to a Cloud-based QMS that is Scalable in Support of a Much Needed Digital Transformation in the Industry

By: Sandra K. Rodriguez, Market Analyst

The Sparta Systems management team recently briefed Axendia on the newly unveiled TrackWise Digital cloud quality management system software platform.  The company, founded in 1994, has undergone several key changes as of late such as a recent acquisition by private equity group New Mountain Capital, and new executive leadership in Dana Jones, CEO  and Vinit Doshi, COO who both joined the company earlier this year.

In addition to TrackWise Digital, Sparta still offers the solution it is perhaps best known for – TrackWise, an enterprise QMS platform.  Although it is a traditional on-prem application, Sparta offers extended cloud capabilities such as quality event intake and supplier collaboration by utilizing a hybrid architecture and seamless user experience.

“Sparta Systems has been a leader in quality management software for the pharmaceutical, medical device, consumer product, and discrete manufacturing industries for over decades. In 2016, Sparta acquired cloud QMS platform 123Compliance, and following a two-year period of heavy investment, rebranded the platform as TrackWise Digital to signal that in our view, it is now equal to our legacy TrackWise platform,” said Brandon Henning, Director of Product Management for TrackWise Digital. Continue reading

30Apr/18
Jumping

Change is a Constant, Why is it So Challenging…

By: Tamara Briggs, Process Improvement Analyst

History has taught us that the only constant is change, however in today’s industries, the rate of change is happening at an increasingly, unmanageable rate.  Axendia’s research on the future of change and configuration management revealed that over 50% of industry professionals worry that their current processes are too slow and cumbersome.

Daniel Matlis, President of Axendia, and Mike Jovanis, Vice President of Vault Quality at Veeva Systems, shared their perspectives on the challenges of change management in FDA regulated industries during an FDANews Webinar.  Specifically, they discussed the importance of simplifying change management across the product life cycle.  Topics of discussion included:

  • Change Management Challenges
  • Closed-loop Quality Processes
  • Collaborating on Change Management
  • Moving from Documents to Structured Data
  • Becoming a Proactive Quality Organization
  • Transforming Change Management Programs

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07Feb/18
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Modernizing Quality Management with Veeva Vault QMS

Veeva Systems Analyst Brief

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by Mike Jovanis, vice president of Vault Quality at Veeva Systems.  Veeva Systems (www.veeva.com) is a cloud computing company focused on the pharmaceutical and life sciences industry.

Veeva Vault Quality customers – companies who own Veeva Vault QualityDocs or Vault QMS – continue to increase in numbers and now include five of the top 20 largest pharmaceutical companies. Launched just a little over a year ago, more than 40 companies have selected Vault QMS ­— and is quickly displacing its competitors.

Historically, quality management solutions have been implemented in a reactionary manner, were on premise, and required extensive configuration to meet user requirements.  “The success of Vault QMS rests on the fact that we are committed to providing best practices, not just infinite configurability,” said Jovanis.  “The true value in using the Vault Quality Suite of applications is that they support end-to-end processes across functional areas and internal and external stakeholders for greater visibility and control,” he added. Continue reading