Pharmaceutical manufacturing operations come in all shapes and sizes. From pilot sites producing several batches a year, to multi-facility production efforts, scalable solutions are essential for digitalization. Digitalization ambitions seem to be at odds when exploring eliminating paper from a manufacturing floor.
How do we balance digitalization ambitions to eliminate paper, while ensuring each and every step is properly documented and verified by the appropriate personnel?
Documentation is essential for pharmaceutical and medical device operations at all scales. Digital solutions must meet regulatory requirements and must be highly scalable to local, regional, or global process needs, regardless of digitalization ambitions. Processes and actions must be appropriately recorded and addressed to ensure regulatory compliance and production integrity across the value stream.