Leading Companies Modernize Quality Management in the Cloud

Veeva Briefing Note

By: Sandra K. Rodriguez, Sr. Industry Analyst

Axendia was recently briefed by Mike Jovanis, vice president of Vault Quality and Kent Malmros, senior director of Vault Training 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 continue to increase in numbers and now include 14 of the top 20 largest pharmaceutical companies. Leading companies around the world are adopting a cloud culture to lower the cost of implementation and ownership, enable collaboration with external partners, and simplify business processes.  To date, more than 175 biopharma, contract manufacturers, generics, and medtech companies, have adopted Vault QMS to streamline and automate quality processes. “As a trusted partner, Veeva has been collaborating closely with life sciences companies globally on their digital quality initiatives,” said Mike Jovanis, vice president, Veeva Vault Quality. “We are committed to customer success and will continue to deliver customer-focused innovation across product development and manufacturing.”

Vault QMS is part of the Veeva Vault Quality Suite, including Vault Product Surveillance, Vault QualityDocs, Vault Station Manager, and Vault Training to automate and harmonize quality processes globally.

Veeva’s continuous innovation is helping customers proactively manage quality and increase agility. Over the last year, new features for Vault QMS include:

  • Seamless connection between Vault QMS and Veeva Vault Registrations to reduce cycle time and increase transparency within post-market change control
  • Quality Risk Management (QRM) advancements, including FMEA methodology to support proactive identification and mitigation of risks
  • Fully automated process for external auditees such as CMOs and suppliers to respond to audit findings directly within the system

In addition, Veeva has added 100+ Vault Training customers, two of which are enterprise customers.  Life-Science organizations are driving towards unified training technologies that connect training outcomes to other critical processes. This year, the company intends to expand to larger companies who have broader enterprise training needs. “With Vault Training, Veeva is improving the industry’s approach to role-based qualification and training compliance,” said Kent Malmros, senior director, Veeva Vault Training. “We are excited to see that growing number of life sciences companies are making training a strategic priority and using Vault Training to meet the evolving learning needs of their organization.”

The company has also introduced Quality Content Reference Model, which includes proven best practices refined over 300+ customer implementations and will help companies save months of efforts in defining document structure and taxonomy. Taking document types, lifecycles and hierarchies into account, the model is publicly available. 

We will continue to provide updates on the Vault Platform as they become available.  

Contact Research@axendia.com to schedule an Analyst Inquiry on this topic.

The opinions and analysis expressed in this Briefing Note reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This document is not intended to endorse any company or product and should not be attributed as such.