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
Going paperless in a regulated industry
The key benefit of the EMS at Fujirebio is the time saved as a result of going paperless. This is especially important for Fujirebio because they belong in a regulated industry. Just take a look at the savings that they get in a variety of their operations:
Logging Data: 439 hours
Check Charts On Recorders: 230 hours
Change Charts: 30 hours
Prep & Review Doc Package: 89 hours
Dept Review Doc Package: 112 hours
QA Review
Doc Package: 192 hours
The automatic logging and paperless reporting saves Fujirebio a total of about 1,100 hours per year.
"Going paperless has saved us a huge amount of time… and it has freed us up to do other aspects of our job. I’m saving approximately 2/3 of my time … or about 10 hours per month by using the EMS system."
Cynthia Travia
Quality Assurance Analyst
More information
In my next post, I will talk about the Workflow solution at Fujirebio. In the meantime, you can check out the following:
Take care,
Jay
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