Data shows that more than half of all FDA recalls of medical devices have been caused by packaging and/or labeling errors. What is the best way to survive an FDA recall? Make sure you are compliant not only by fixing the recall issue, but preparing for the future.
Comprising a full suite of label and barcode printing applications based on the Oracle Database, PRISYM 360 offers integration to your current manufacturing and ERP systems. PRISYM 360 ensures that your business can meet the labeling requirements for serialized and other Life Sciences products now and in the future.
The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulate a transformation of labeling infrastructure and approach among global device manufacturers.
The introduction of Unique Device Identification (UDI)regulations signals a seismic shift in theMaintaining an efficient supply chain is widely acknowledged as a key strategic imperative for businesses across the global life science sectors.