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 ( 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.Axendia Briefing Graphic

Early adopters of Vault QMS are modernizing quality management. The main drivers are globalization, outsourcing, aging solutions, and the need to simplify complexity.  More specifically, customers are willing to invest in solutions that proactively address the following:

  • Support continued trend toward globalization and outsourcing and enabling companies to easily bring together internal and external partners on one platform
  • Achieve process optimization that has been difficult with aging solutions
    • Existing solutions are often implemented reactively
    • They can be confining and do not support agile processes
    • Typically they do not meet today’s user experience expectations
  • Simplify complexity with a single platform for seamless process and document management. Complex processes such as change management are easier to support with a unified solution

2017 Release Highlights

Vault QMS enhancements (subset):

  • Enhanced reporting across quality event types
  • Atomic field and action-level security – Ability to restrict security based on combination of lifecycle state and role
  • Formatted output – Print data that has been formatted to include text, images, and tables such as audit reports containing related CAPA information, or printable ‘Configuration Change Ticket’ complete with closure date information
  • Flash reports – Schedule and automatically distribute reports on a daily, weekly, or monthly frequency
  • Java SDK – Support custom business logic that executes when users perform a specific action

Vault QualityDocs enhancements (subset):

  • Version specific attachments
  • User mentions in annotations – Notify a user about an annotation by adding ‘user mentions’ e.g., @johnsmith
  • Merge fields for password enabled templates – Allow specific fields in MS Worddocuments to be replaced with data e.g., having a document field point populated with the product family name

Drug safety is also on the horizon for Veeva.   A new application, Veeva Vault Safety will be available in 2019 and will join Vault Quality, Veeva Vault Clinical, and Veeva Vault RIM as part of the Veeva Development Cloud.




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