With a more than 20-year reputation as a trusted source of innovative solutions in clinical diagnostics, Fujirebio Diagnostics, Inc.’s proven manufacturing process for the production of biomarkers has made it a global partner of choice among leading diagnostics companies around the world.Project goal: To replace an existing paper-based GMP record system and manual process with an electronic monitoring system
Being in the life sciences
industry, Fujirebio adheres to a strict manufacturing processes.
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.
The “Gold Standard” Biomarkers for Oncology
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 system.
“The biomarkers manufactured by Fujirebio are basically
blood tests, and our core competency is in oncology. The products which we have
intellectual property for are mainly centered on cancer testing."
Mike Koch, Vice President of Supply Chain
A major milestone was achieved at Fujirebio on July 1, 2013 when its manual, paper-based process of periodically recording temperature readings for specific manufacturing equipment was officially replaced by a new computerized system.
More Information
Over the next week or so, I will be talking about how Fujirebio used Wonderware Workflow to create this new computerized system they call the Equipment Monitoring System. In the mean time, please visit the following links for more information:
Till then,
Jay
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