We have successfully delivered a GMP validated custom FACS data management system to the quality control (QC) laboratories at Bavarian Nordic, based on the Scifeon data management platform.
The system replaces several complex Excel templates that suffered from the typical pains of file-based solutions:
The new system covers the process from experiment design to report approval, with a wide set of custom features:
The system is going to be used in pharmaceutical QC labs and therefore has been validated to match GMP and FDA 21 CFR Part 11 requirements.
We are using automated testing of the software, enabling fast re-testing when new functionality is needed. With this system, new IT functionality can be implemented and workflow changes accommodated with a faster validation process. This is a game-changer by making it much easier to realize the benefits of modern IT in regulated laboratories, and we are working with Bavarian Nordic in our continued effort to make frequent updates to IT systems for regulated laboratories a reality.
The project is run as a co-creation effort with close collaboration between Bavarian Nordic and Scifeon staff. We use an agile development process with frequent, small updates that let the end users try the system at an early stage and provide feedback, thus making sure that we end up with the right system in a short time. This approach minimizes project risks, both regarding system suitability and cost.
This project was started in November of 2017; the system went into production use in February of 2018 and GMP validation was completed in June 2018.
Successful implementation of a complex, heavily customized IT system for a regulated laboratory in such a short time demonstrates the power of the Scifeon platform as well as the agile software development process.