Bavarian Nordic

GMP Validated FACS Data Management

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:

  • Manual data processing; time-consuming and error-prone
  • Lack of flexibility
  • Copy-n-paste’ing data, manually compiling data from several Excel files into summary sheets
  • Lots of paper for compliance

System features

The new system covers the process from experiment design to report approval, with a wide set of custom features:

  • Automated import of sample information from a freezer inventory system
  • Custom experiment setup, implementing SOP elements to reduce the need for remembering procedural details
  • Direct import of different types of result files from Becton Dickinson Diva software (and an easy way to add support for new file formats)
  • Custom data analysis, including the various calculations and compliance evaluations of SOP based acceptance criteria
  • Managing the variation of acceptance criteria for different SOPs and positive control batches
  • Managing custom report approval and signature workflows
  • FDA 21 CFR Part 11 compliant electronic signing of study reports
  • Electronic filing of signed reports; no need for paper-based records

GMP Validation

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.

Process

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.

Why Scifeon

Scifeon is built as a development platform first, because customization to match your workflows is critical for your success with implementation of a data management system. With Scifeon, your lab is not forced into a pre-defined workflow scaffold.