Fujirebio is a Japanese multinational biotechnology company, founded and headquartered in Tokyo, Japan, and present locally with offices in Japan, Asia, Europe and the United States and through a large international distribution network. The company has manufacturing facilities in Japan, Europe and the United States.
Fujirebio specializes in innovation, development, manufacturing, and marketing of in vitro diagnostics (IVD) testing reagents, instruments, and software for clinical diagnostics and for research use. Fujirebio is today an H.U. Group company (listed on the Tokyo Stock Exchange - TYO: 4544).
Fujirebio was founded in Tokyo, Japan in 1950 under the name Fujizoki Pharmaceutical, Co., Inc. In its early days the company developed and manufactured pharmaceutical products.
Goals
- To replace an existing paper-based GMP record system and manual process with an electronic monitoring system
Challenges
- A significant amount of time is spent each day manually reviewing reports.
- The existing paper-based system was time consuming and vulnerable to reporting errors.
- A new system must enable the company to remain in compliance with federal regulation.
Solutions
- AVEVA™ System Platform
- AVEVA™ Work Tasks
- AVEVA™ Historian
- AVEVA™ InTouch HMI
Results
- 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 equipment monitoring system saves about 1,100 man-hours per year.
- 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.
- Electronic monitoring saves 2/3 of time, or about 10 hours per month in quality assurance.
“The largest benefit of the equipment monitoring system is that we are logging automatically now rather than manually, so it’s saving us about 1,100 man-hours per year.”
Josh Zimmer, Quality Engineer, Fujirebio Diagnostics, Inc