The data elements are consistent with Standardized Numerical Identifier (SNI). SNI guidance discussed GS1 standards by stating you can use GS1 standards to generate what the FDA considers an SNI. The DSCSA refers to SNI in the draft guidance, which is a direct reference to SNI guidance from 2010. On another related topic that sometimes causes confusion, the SNI guidance allowed for additional attributes to be encoded in the barcode if desired (such as Lot and Expiry), there is no conflict at all between the SNI guidance document.

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

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