Scifeon successfully delivered a customized GMP Validated FACS Data Management System to the Bavarian Nordic QC Labs
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
- Manually compiling data from Excel files into summary sheets
- Lots of paper for compliance
Bavarian Nordic replaced several very complex Excel templates and elaborate manual data processing with a customized Scifeon system that provides:
- Improved flexibility in experimental designs
- Automated data processing reducing the risk of errors
- Stronger analytics, without the need for manually compiling data from different Excel files electronic signatures and document filing
The system is used in Pharmaceutical Quality Control labs and therefore has been validated to match GMP and FDA 21 CFR Part 11 requirements.
Scifeon is 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 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