Case Study: Fujirebio Diagnostics, Inc. achieves paperless GMP compliance and saves 1,100 man‑hours/year with AVEVA

Fujirebio Diagnostics Implements Paperless Electronic Initiative for its Biomarker Manufacturing

Fujirebio Diagnostics, Inc., a life‑sciences manufacturer of oncology biomarkers, faced a time‑consuming, paper‑based GMP records process that required daily manual review and risked reporting errors while needing to remain 21 CFR compliant. To replace that system and streamline compliance, Fujirebio turned to AVEVA (Wonderware by AVEVA) to implement an electronic monitoring and records initiative.

AVEVA deployed System Platform, Workflow Management, Historian and InTouch HMI as an Equipment Monitoring System (EMS) to capture equipment data, generate electronic GMP reports and enable electronic signatures and review‑by‑exception. The AVEVA solution made Fujirebio fully paperless, preserved 21 CFR Part 11 and ISO 9001/13485 compliance, cut manual review from 15+ hours to minutes, saved about 1,100 man‑hours per year (roughly two‑thirds of QA time or ~10 hours/month), and delivered a scalable platform for future automation.

Fujirebio Diagnostics, Inc.

Josh Zimmer

Quality Engineerr