Category Archives: Cloud

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
veeva logo

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

29Jan/18
Living-heart-project

SIMULIA is Modeling Humans from Head to Toe –Literally!

Dassault Systèmes SIMULIA Analyst Brief

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by executives of the SIMULIA brand of Dassault Systèmes. The SIMULIA brand is responsible for developing realistic 3D simulation and design optimization applications that complement the integrated solutions of Dassault Systèmes 3DEXPERIENCE® platform..

Dassault Systèmes purpose is to provide business and people with 3DEXPERIENCE universes to imagine sustainable innovations capable of harmonizing product, nature and life.   Proof of the company’s long-term commitment to simulation comes with it latest acquisition, Exa Corporation.  A Boston-based company, Exa has a global presence and customer base with reported $72M in revenue for the fiscal year ending January 2017.  Exa is focused on serving the ground transportation,  aerospace, and oil & gas industries and has deep experience in fluid mechanics and simulation.  Dassault Systèmes acquired the company on November 17, 2017.

As part of Dassault Systèmes’ Life Science and Virtual Human Modeling (VHM) update, Steven Levine, Senior Director, SIMULIA Virtual Human Modeling, stated, “SIMULIA VHM is based on two principles:  If you want to design a great user experience, you must include the user in the design.  Healthcare is still in the 1D or 2D world, it’s time we bring them in to 3D to help demystify the complexity of  the human body.”

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03Nov/17
CLOUD IMAGE

ComplianceQuest Offers Cloud Native Enterprise Quality Management Solutions

By: Daniel R. Matlis

Axendia was recently briefed by ComplianceQuest’s executive team.  The team, 80% of whom have deep experience in the Enterprise Quality Management Solutions (EQMS) market, has developed a cloud native EQMS built on the Salesforce platform.

ComplianceQuest was developed on the Salesforce cloud solution to provide a worry-free infrastructure platform that can be available anywhere, anytime. In addition, Salesforce provides a reliable, versatile infrastructure that can scale for all size companies. Another benefit of developing on the Salesforce platform is the ability to leverage advanced capabilities such as mobility, social media, artificial intelligence and machine learning and be ready for future technologies.Network_Navy_F

“ComplianceQuest provides a unique combination of niche experience, solutions and services across multiple industries with comprehensive capabilities in quality, safety and compliance throughout the supply chain,” said Nikki Willett, Chief Strategy Officer at ComplianceQuest. “Suitable for small companies and secure, scalable and flexible to meet the needs of medium and global enterprises, ComplianceQuest is easy to implement, validate and use,” she added.

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