Cleaning Up The Systems Mess: A Phased Approach To Implementing Real Automation And EBRS
By Herman F. Bozenhardt and Erich H. Bozenhardt
The pharmaceutical industry uses the most sophisticated microbiological and genomic technology, and we experience waves of advancements in therapies, all driven by our computing and communications technology. In addition, we as a culture are nearly physically glued to our smartphones/devices that manage our business and personal lives. We bitterly complain when we enter a facility with “poor” Wi-Fi reception and downloads take 10 seconds instead of happening in the customary flash.
So, when we go to work (laptops in hand) in pharmaceutical production, why are we drowning in 100-page paper batch records, books of SOPs on the plant floor, and paper documents being handled by operators and operations support personnel throughout the buildings? Why do we cheer and celebrate when we can get a paper batch record approved and out the door in 40 days rather than the average of 65 days? Why do we track the number of deviations (mostly clerical/document oriented) on the batch records as a measure of success and efficiency? How will this paper-laden environment work as personalized therapies/precision medicine become a bigger part of our industry?
