Insights

Beyondsoft Helps a Leading Genomics Company Automate GxP compliance, Reducing Software Release Cycle by 15% 

Author: Rohit Garg

THE CHALLENGE

A global leader in genomics technologies headquartered in the USA was facing significant challenges in ensuring compliance with GxP (Good Practice) standards, specifically in validating their cloud-based Software as a Medical Device (SaMD) platform. This platform supports next-generation sequencing (NGS), simplifying data management, accelerating analysis, and fostering collaboration within a secure cloud ecosystem. However, maintaining GxP compliance, particularly Computerized System Validation (CSV), was proving to be time-consuming and labor-intensive. Manual validation processes were slowing down the development cycle, hindering the company’s ability to quickly deliver new features and updates to their customers. 

For companies in the life sciences sector, compliance with standards like FDA 21 CFR Part 11 and EU GMP is crucial. These regulations ensure the safety and effectiveness of medical devices and software, making GxP compliance essential for market entry and ongoing product approval. In the context of software, GxP compliance requires validation processes that generate objective evidence to prove that systems perform as intended. Manual execution, logging, and verification of these processes, however, consume significant resources and time, making it difficult to adopt agile development practices. 

The company needed a partner capable of delivering GxP-compliant validation services without slowing down its release cycles. With our rich experience in hardware and software testing and automation, the client selected us to simplify their workflow. 

THE SOLUTION

We partnered with the client to implement a solution that would simplify their GxP compliance processes without sacrificing quality or speed. Drawing on our extensive experience in both hardware and software validation, we established a Testing Center of Excellence and integrated an automated test suite into their DevOps pipeline.

Key aspects of our approach included:

• Automated Test Suite: We developed a robust, scalable automated test suite that handled GxP-compliant validation tasks, ensuring that the required audit trail and objective evidence were generated for every release. 
• Integrated DevOps Pipeline: By integrating the test suite into the platform’s existing DevOps pipeline, we enabled faster, repeatable regression testing at the click of a button, significantly reducing the manual effort involved in validation. 
• Auditable Validation Trace: The automation solution generated detailed logs and validation evidence that could be easily audited, ensuring full GxP compliance without additional manual verification. 

This approach allowed the company to meet stringent GxP standards while maintaining an agile development process. Instead of relying on manual validation efforts that required constant oversight, the automation solution generated consistent, verifiable results, reducing both time and effort for compliance engineers. 

THE RESULTS

Our partnership delivered significant benefits for the client: 

• Cycle Time Reduction: Automated validation reduced the software release cycle time by 15-18%, enabling the company to deliver updates faster without compromising on quality. 
• GxP Compliance: The solution provided full GxP compliance, ensuring the platform met regulatory requirements for safety and effectiveness, a critical component for the company’s market entry and approval. 
• Effort and Cost Optimization: Automation minimized the need for manual intervention in the validation process, reducing overall effort and associated costs with each incremental release. 
• Auditable Validation Trace: Our solution ensured that each test run produced the necessary audit trails, reducing the burden on compliance engineers and simplifying the review process. 

We are proud to have delivered a test automation and performance suite that reduced the software release cycle time by 15-18%, enabling faster updates while ensuring full GxP compliance for regulatory approval. This solution also minimized manual validation efforts, optimizing both cost and efficiency while providing auditable validation trails to simplify compliance reviews.

Rohit Garg, Director, Account Management for Life Sciences, Healthcare & Digital Interactive

We continue to enhance the automated regression test suite to support the current platform, ensuring compliance as the company evolves. Additionally, we are expanding the automation framework to include other product lines, further optimizing their software validation efforts across the board. 

For organizations in the life sciences and biotechnology fields, ensuring GxP compliance can often slow down development cycles and increase costs. However, with the right approach to automation and validation, it’s possible to achieve both regulatory compliance and rapid product iteration. Our work with this global genomics leader demonstrates how test automation can deliver tangible benefits, from reducing cycle times to optimizing effort and cost. 

NEXT STEPS

Are you looking to optimize your GxP compliance processes while maintaining the speed of innovation? Contact us today and let us explore the future together.