1,100 hours per year are saved at Fujirebio

Fujirebio makes biomarkers (i.e., blood tests) and its core competency is in the oncology area so its products are mainly centered around cancer testing. The product it manufactures annually is quite considerable.  At their Malvern, Pennsylvania plant, they produce about 75 million tests that are then 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

 

What makes the solution at Fujirebio unique?

The EMS provides us a way of archiving data and it allows us to trend the way that our equipment is operating to make sure it’s staying within specification and up to our standards. 

Josh Zimmer
Quality Engineer

What makes the solution unique?

1. It is a complete paperless system with electronic records and electronic signatures
2. It generates18 Monthly Department Reports for “Review By Exception” 
3. It routes reports for review and approval via the Wonderware Workflow software

More information

In my next post, I will talk about what going paperless did for Fujirebio. In the meantime, you can check out the following:

1. Wonderware Workflow
2. Wonderware System Platform

Take care,
Jay