Labeling core to patient safety draws constant scrutiny and often findings from health authorities.
Big Pharma Challenges:
- Sometimes embedded in Regulatory and often less important in terms of resources or budgets (especially when these are de-centralized)
- Usually, most of the labeling is manual, copy/paste & repetitive, manual reconciliations of data points, a lot of QC checklists, and so on
- Heavily document focused and digitization is always “next year” project
- Having separate labeling focused software tough to justify cost and sustenance
Mid/Small Pharma Challenges:
- With fewer products in the market, a labeling system not on priority to the Finance team
- Maintained in documents (on desktops, shared drives, or general EDMS) and with less traceability
- Less time left for actual “science” work
- Knowledge in fewer hands (out of the door when they leave)
