The regulatory requirements in the pharmaceutical and biotechnology industry are much higher than in other sectors
In order to fulfill these requirements, the processes in use must be transparent and verifiable at all times. Enterprise Manufacturing Intelligence (EMI) solutions provide uninterrupted monitoring of your entire data material, record it, and derive process improvements from it. In addition to laboratory and production data, it also includes material, HR, and production data and the capability to do so much more.
The right data model is decisive for this to work optimally. Make use of our consulting expertise and learn how you can transform your production data into valuable knowledge with the help of EMI. We create for you a central portal from which the data for dashboards or reports are provided in standardized form. Of course, we also take care of the validation of the data model and its applications.
We provide our services in a validated and regulated environment while taking account of data integrity. Building on this, reports required for regulatory purposes can be made available at any time on a provisional basis. These include Continued Process Verification (CPV), Ongoing Process Verification (OPV), and Annual Product Review (APR), as a few examples.