The creation of the Electronic Initiative at Fujirebio was triggered by a few challenges in the Pennsylvania plant, mainly on the following:
- 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
Innovation Always Starts with an Idea
The project started when the personnel at the Malvern campus identified a major opportunity to save time and paper, while still
retaining compliance by automating the acquisition of equipment data and
generating electronic reports for review and approval.
The solution is called the Electronic
Initiative and the first phase of the implementation is called the Equipment
Monitoring System, or EMS.
“EMS provides us a way of archiving data and it allows us
to trend the way our equipment is operating to make sure its staying within our
specifications and up to our standards”
The function of the EMS
The EMS system at Fujirebio performs a number of very
important functions such as:
- Enabling personnel to monitor equipment from their workstations
- Maintaining all temperature readings in electronic records
- Notifying authorized personnel in the event of adverse temperature trends
- Generating electronic Good Manufacturing Practice (GMP) reports for review by exception
- Providing authorized personnel electronic signature capabilities to approve reports
More information
In my next post, I will talk about the benefits that Fujirebio got from the EMS built on Wonderware software. In the meantime, you can check out the following:
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