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Enhancing Pharmaceutical Quality Assurance Processes for a Leading Company

SQA2 Case Studies: Health Tech

Client Background

Our client, a prominent pharmaceutical company, specializes in building applications that drive and track clinical trials. With a strong commitment to innovation and operational excellence, the client sought to enhance their QA processes to meet the evolving demands of the healthcare industry. These applications are critical for supporting clinical research and ensuring compliance with regulatory standards, making quality assurance (QA) an essential aspect of their operations.

Project Overview

The client embarked on multiple projects, including:

  • Integrating mobile (iOS/Android) devices with Bluetooth medical devices for real-time data tracking in clinical trials.
  • Developing an application to assist personnel in configuring clinical trials before they go live.
  • Implementing robust back-end systems (API/DB) to support patient apps, dashboards, and other applications within their ecosystem.

The primary goal was to improve their QA testing processes and turnaround times, especially as they transitioned from a traditional waterfall methodology to a more agile and responsive approach. The client required a QA service that could keep up with these rapid developments while ensuring the highest standards of software quality and regulatory compliance.

Challenges

Before our involvement, the client faced several challenges:

  • Reliance on Domain Knowledge: The client heavily relied on individual resource domain knowledge rather than comprehensive documentation, which made onboarding and testing processes slower and inconsistent.
  • Waterfall Development Slowing QA: The traditional waterfall methodology further hindered the client’s ability to adapt quickly, leading to slower development and QA cycles.
  • Manual Testing Limitations: The lack of automation resulted in longer regression testing cycles and made it difficult to keep up with frequent updates and new feature rollouts, particularly in critical healthcare applications.

Pharmaceutical Quality Assurance Solutions Implemented

To address these challenges, we implemented several key improvements to the client’s QA processes:

  • Adopting Agile Methodology: We transitioned the client to a true Agile methodology, which allowed for faster iterations and better adaptability to the changing requirements in their projects, especially crucial for pharmaceutical and healthcare applications that often face regulatory changes.
  • Test Case Development: We developed detailed test cases with clear and well-defined steps. These were designed to be easily understood by both technical and non-technical team members, ensuring a broader team participation in the QA process.
  • Defect Management Process: We improved the defect management process by encouraging teams to write detailed and thorough tickets, minimizing back-and-forth communication and reducing delays. We worked closely with project management to ensure the acceptance criteria and requirements were clearly defined, improving the overall quality assurance workflow.
  • Automation Implementation: We implemented automated testing strategies using technologies such as Behave/Behavex and Python. This was particularly beneficial for projects like the application used to configure clinical trial studies. Automated tests were run nightly, catching issues early and significantly improving the turnaround time for regression testing.
  • Optimizing Existing Tools: Although the client had a solid grasp on their tools, they struggled with efficiency. By streamlining the deployment process, we reduced deployment to upper environments from days to minutes, improving both development and QA efforts.
  • Leveraging the SQaaS Model: Our Software Quality as a Service (SQaaS) model provided the client with US-based QA resources at rates competitive with offshore services. This outsourced QA model allowed the client to scale resources as needed while maintaining cost-effectiveness and continuous support.

Outcomes and Results

The implementation of our solutions resulted in significant improvements for the client:

  • Increased Efficiency: The transition to Agile methodology and the introduction of automated testing drastically reduced the time required for testing and deployment. Our team was able to complete regression testing in less than 16 hours by combining both automation and manual efforts. This was especially crucial for meeting the fast-paced demands of the pharmaceutical industry, where quick iterations are essential for clinical trial applications.
  • Enhanced Test Coverage: The regression suite expanded, and automation coverage increased, resulting in a more comprehensive testing process. This not only improved the quality of the software but also ensured faster release cycles, enabling the client to stay competitive in the healthcare and pharmaceutical sectors.
  • Cost Savings and Scalability: The flexibility of our SQaaS model allowed the client to scale resources up and down as needed, providing both cost-effectiveness and adaptability. This approach made the client’s QA testing services a cost-saving center rather than a cost center, as the faster development and release cycles resulted in significant savings.

Client Satisfaction

The client’s satisfaction with our work is evident through their long-term partnership with us, spanning several years and involving us in more projects across their organization. Over time, they have increased our involvement significantly, reflecting their trust in our QA capabilities. For instance, the resources we provide have grown by over 150%, starting from 1 embedded team member and 2 SQaaS resources to our current team of 4 embedded team members and 5 SQaaS resources. This expansion underscores the client’s confidence in our ability to deliver quality results and adapt to their evolving needs in the pharmaceutical industry.

Future Outlook

We continue to work closely with the client on ongoing projects, with plans to further integrate our processes and expand our role within their organization. Our goal is to help the client become advocates for a true Agile methodology across their projects. The flexibility and cost-effectiveness of our SQaaS model will continue to provide value, offering US-based resources at offshore rates and ensuring continuous support as the client’s needs evolve.

As the pharmaceutical and healthcare industries continue to advance, especially with the increasing complexity of clinical trial applications and medical devices, we are committed to supporting the client with innovative QA solutions, including further development of automated testing and QA testing services tailored to the unique demands of healthcare software.

Conclusion

By leveraging SQA²’s QA services, we were able to transform the client’s QA processes, improving efficiency, increasing test automation coverage, and reducing turnaround times. Our blended approach, combining the SQaaS model with embedded team members, provided the client with scalable, flexible, and cost-effective solutions to meet the fast-paced demands of the pharmaceutical industry.

What began as a partnership to improve QA testing has evolved into a long-term collaboration, with SQA² continuing to play an essential role in the client’s success. Our ability to deliver high-quality outsourced QA services at competitive rates, while also adapting to the evolving needs of the healthcare sector, ensures that our client can focus on delivering innovative and compliant solutions to the pharmaceutical industry.

Contact Us

At SQA², we specialize in providing flexible, scalable, and cost-effective QA solutions designed to meet the unique demands of industries like pharmaceuticals and healthcare. Whether you need automated testing, agile QA processes, or continuous support for your software development lifecycle, our SQaaS model offers US-based QA resources at rates competitive with offshore services.

Reach out to us today to discover how we can help enhance your QA processes, improve efficiency, and ensure the quality and compliance of your software applications.

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