Case Study: Bavarian Nordic streamlines GMP-validated FACS data management with Scifeon

Bavarian Nordic streamlines GMP FACS data management with Scifeon and 21 CFR Part 11 compliance

Bavarian Nordic faced challenges in its QC labs with manual, error-prone data processing using complex Excel templates. These file-based solutions required time-consuming compilation of data and extensive paper records for compliance. They partnered with Scifeon to implement a GMP-Validated FACS Data Management System to address these issues.

Scifeon delivered a customized system that automated data processing, reducing errors and the need for manual work. The solution provided stronger analytics and electronic signatures, eliminating paper-based records. The platform was validated for GMP and FDA 21 CFR Part 11 compliance, enabling faster implementation of new IT functionality and workflow changes.

Bavarian Nordic