The Client

Our client, one of the world’s largest biopharmaceutical companies, chose Tx3 for our expertise in helping life sciences organizations improve their validation and approval process. Focused on treatments for cancer and immune and inflammatory conditions, the client needed help adopting an Agile approach while remaining FDA compliant.

The  Challenge

Like many life sciences organizations, our client understood the importance of implementing a software quality process that was both user-friendly and audit-ready. They were also interested in moving away from a Waterfall to a DevOps methodology, and they had invested substantially in testing tools to help them do so.

However, the initial implementation of these tools was fragmented. The lack of integration among systems forced personnel to log into multiple systems with different data approval processes. At times, the process even required the manual entry of redundant data.

Additionally, the poor fit between methodologies made it difficult to apply a formal review of automated test scripts within the various testing tools. The disparate technology also resulted in poor traceability, placing the client at risk for non-compliance.

The Solution

The client’s existing tech stack included Tricentis Tosca, Atlassian JIRA, Blueprint, Micro Focus ALM, and ServiceNow. To synchronize these disparate tools, we deployed VERA, our industry-leading Digital Validation platform. Seamlessly integrating with legacy software and designed to meet FDA regulations, VERA supplies a single user interface for the approval and CSV process.

"VERA gives clients a simple-to-use, unified view of their validation process. Integrating key data between systems saves time and reduces the risk of human error." - Eric Toburen, Managing Partner and Co-Founder

Key Components 

• Real-time reporting and analytics for faster, more compliant development.
  
  
• Ability to leverage Agile management tools in a regulated environment.
  
  
• Ability to build repositories of approved reusable requirements, user stories, specifications, test scripts, and more.
  
  
• Incorporating Test Automation to enhance CSV and GxP software testing.
  
  
• Control and governance of data across the software testing life cycle.
  
  
• Simple integration with best-in-breed technology.

The  Benefits

The client now enjoys a range of benefits that would not be possible within a document-centric Waterfall approach. The integrated solution provides data synchronization and end-to-end traceability across the DevOps tools landscape, accelerating time-to-market while drastically reducing the risk of human error.

After undergoing training in VERA’s easy-to-use platform, the team is equipped with automated Agile approval processes and audit trails with full traceability that can be generated on demand. The client is now poised to take advantage of leading technology and synchronize its data while remaining compliant with regulatory requirements.

See VERA in Action

Want to see what VERA can do to advance and enhance CSV at your organization? Reach out and schedule a demo to see VERA in action!