In the highly regulated biotech sector (where quality and compliance are critical), our client, a Danish biotech company, stands at the forefront of developing innovative human antibody therapies for cancer treatment. Their work requires a relentless commitment to scientific discovery and strict adherence to the rigorous Good Practice (GxP) standards that govern the pharmaceutical and biotech industries.
Balancing the drive for innovation with the need for precision and compliance, they play a key role in advancing life-changing therapies while navigating the complex regulatory landscape. Combining cutting-edge research with a focus on safety and quality, our client continues to set a high standard in developing breakthrough treatments for patients worldwide.
The challenge
Our client faced a multifaceted challenge in implementing Agile ways of working within a GxP-regulated environment. While Agile emphasizes flexibility, iterative development, and rapid deployment, the GxP regulatory framework demands rigorous documentation, validation, and traceability to ensure product safety and efficacy. Aligning these contrasting methodologies required a strategic approach.
Compounding this complexity, the client’s reliance on the Atlassian ecosystem (Jira, Confluence, etc.) for Agile workflows and collaboration was critical but presented additional compliance challenges. Frequent data migrations between environments, from development to testing, were necessary for configuration validation. However, Atlassian’s setup (especially when integrating third-party apps) lacked the capability for seamless 1:1 data transfers, which created additional risk and resource demands. The situation was further complicated by an unexpected change in staffing, which left key tools unvalidated and introduced compliance risks, delaying progress and potentially threatening regulatory adherence.
Together, these issues underscored the difficulty of balancing Agile transformation with the stringent requirements of GxP compliance.
The project journey
Our original plan was to implement a streamlined GxP-compliant process to support Agile practices, but we quickly realized the ecosystem’s complexity required a more nuanced approach. We stepped in and took over the project, which led us to develop a highly detailed process that prioritized configuration accuracy and extensive documentation for migration steps. That allowed us to validate and migrate the configurations without error-prone human interaction.
We aimed to automate the client’s QA processes wherever possible to boost compliance efficiency. Based on the team's input, we made various change requests to align with regulatory and Agile development requirements. Additionally, we validated critical applications, documented all configurations and migration procedures, and produced a reusable, comprehensive guide for future reference.
To address limitations with the Atlassian suite, we researched and implemented an optimal backup and restore solution, ensuring data integrity within the ecosystem’s constraints. We migrated configurations with minimal disruption and developed a specialized validation tool to support GxP compliance. This tool captures and compares Jira configurations across instances, helping preserve state consistency by flagging any deviations. Additionally, we resolved matters that involved the workflows themselves and raised issues to app developers to support us in bug fixing.
Closing thoughts
Overall, this project highlighted our commitment to enabling Agile development in highly regulated environments. By carefully analyzing, documenting, and developing specialized tools, we helped the client maintain GxP compliance while aligning with Agile practices.
Published: Jan 3, 2025
