Case Study: Fujirebio Diagnostics achieves paperless GMP compliance and saves 1,100 man-hours per year with Wonderware

Fujirebio Diagnostics implements Wonderware Workflow

Fujirebio Diagnostics, Inc., a Malvern-based leader in biomarker assays that manufactures about 75 million tests a year, faced a time-consuming, error-prone paper-based GMP record system. Daily manual logging and lengthy report reviews threatened efficiency and posed risks for maintaining strict regulatory compliance (21 CFR Part 11, ISO 9001 and 13485).

To address this, Fujirebio deployed an Electronic Initiative—an Equipment Monitoring System built on Wonderware System Platform, Workflow, Historian and InTouch—to automate equipment monitoring, electronic record capture and signature-driven review-by-exception. The paperless EMS eliminated manual logging, cut review time from 15+ hours to minutes, saved roughly 1,100 man-hours per year (about two-thirds of QA time or ~10 hours/month), maintained compliance, and provided a scalable foundation for future automation projects.

Fujirebio Diagnostics

Josh Zimmer

Quality Engineer