Case Study: Fujirebio Diagnostics achieves paperless compliance and major time savings with Wonderware West

Fujirebio Diagnostics implements Wonderware Workflow

Fujirebio Diagnostics, Inc., a global clinical diagnostics manufacturer, needed to replace a paper-based GMP record system and manual equipment monitoring process while staying compliant with FDA 21 CFR Part 11 and other quality standards. The company was spending significant time each day reviewing reports and managing paper logs, and it needed a more accurate, efficient electronic monitoring approach. Wonderware West’s software, including Wonderware Workflow/Skelta BPM and Wonderware System Platform, was used to support the initiative.

Wonderware West implemented a paperless equipment monitoring system that electronically captured temperature data, generated GMP reports for review by exception, and enabled electronic signatures and automated approvals. The results were substantial: Fujirebio saved about 1,100 man hours per year, cut data review from more than 15 hours to just minutes, and reduced quality assurance time by about two-thirds, or roughly 10 hours per month. The solution also helped support production of 75 million tests annually while maintaining compliance and creating a scalable foundation for future automation projects.

Fujirebio Diagnostics, Inc.

Mike Koch

Vice President of Supply Chain