OmniMedia Associates


The US DQSA of 2013 mandates unit and homogenous case serialization. Most international requirements also mandate serialization, at least at the unit level.

Serialization is the process of providing a unique identifier on each package - usually the "smallest saleable unit" - and then communicating this information with each transaction or logistical change. The FDA issued guidance on serialization - that can be found here
When California's ePedigree law was passed a decade ago, most industry professionals and regulators assumed that the serialization media would be RFID tags. RFID has the advantage of being a "non-line-of-sight" technology. This meant that scanners would be able to know the identity of the units inside a case or pallet without opening said case or pallet.  RFID proved much too costly and unreliable at that time to be used in that kind of scale (4B units per year in the US). So, the industry decided on using 2D barcode to serialize despite that being a "line-of-sight" technology - meaning you'd need to look at it to read it. The DQSA specifically calls out 2D barcoding as serialization media.
2D, while less expensive than RFID, has precipitated the eventual use of aggregation and re-aggregation technologies to create and re-create parent /child relationship among packaging types depending on regulatory rules. Serialization has profound effects on production, packaging, shipping logistics, security, sales and IT - among others! OMA is ready to work with you to develop an achievable compliance project. In addition to the strategy, we can provide the people necessary to make it happen - contact us today for a consult.