AVEVA (Schneider Electric) Case Studies Fujirebio Diagnostics Implements Paperless Electronic Initiative for its Biomarker Manufacturing
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Fujirebio Diagnostics Implements Paperless Electronic Initiative for its Biomarker Manufacturing

AVEVA (Schneider Electric)
Functional Applications - Enterprise Resource Planning Systems (ERP)
Life Sciences
Quality Assurance
Discrete Manufacturing
Manufacturing System Automation
Predictive Maintenance
System Integration
Software Design & Engineering Services
Fujirebio Diagnostics, a trusted source of innovative solutions in clinical diagnostics, was facing challenges with its existing paper-based GMP record system and manual process. The company was spending significant time each day manually reviewing reports. The paper-based system was not only time-consuming but also vulnerable to reporting errors. Moreover, any new system implemented had to enable the company to remain in compliance with federal regulation.
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Fujirebio Diagnostics, Inc. is a global partner of choice among leading diagnostics companies around the world. With a reputation of more than 20 years as a trusted source of innovative solutions in clinical diagnostics, Fujirebio’s proven manufacturing process for the production of biomarkers has made it a global partner of choice among leading diagnostics companies around the world. Being in the life sciences industry, Fujirebio adheres to a strict manufacturing process which is based on Wonderware by AVEVA. These processes are certified with compliance for reporting and documentation requirements that are very detailed and extensive. The biomarkers produced by Fujirebio help physicians, lab professionals and patients better manage disease. Over the course of the year, Fujirebio’s 160,000- foot production facility produces about 75 million tests that are distributed throughout the world. It is a FDA-registered facility that is 21 CFR Part 11 compliant, and is both ISO 9001 and ISO 13485 certified for quality systems.
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Fujirebio implemented AVEVA's System Platform, Workflow Management, Historian, and InTouch HMI to replace its existing paper-based system. The solution, called the Electronic Initiative and the first phase of the implementation is called the Equipment Monitoring System (EMS), allows personnel to monitor equipment from their workstations, maintains all temperature readings in electronic records, notifies authorised personnel in the event of adverse temperature trends, generates electronic Good Manufacturing Practice (GMP) reports for review by exception, and provides authorised personnel electronic signature capabilities to approve reports. The EMS system at Fujirebio performs a number of very important functions. Workflow Management is at the heart of Fujirebio’s EMS. What Workflow Management does is digitise and automate Fujirebio’s manual processes that include people, equipment and systems, based on a sophisticated Business Process Management (BPM) foundation standard. This enables staff to generate electronic records and file them automatically.
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The company’s electronic initiative helps produce 75 million tests that are distributed throughout the world
The solution is completely paperless and provides electronic record collection with electronic signatures while maintaining 21 CFR compliance and ISO 9001 and 13485 certification
The tasks related to manually logging equipment parameters and reviewing paper logs and charts is eliminated and has reduced data reviewing time from 15+ hours to just minutes
The equipment monitoring system saves about 1,100 man hours per year
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