Updates for serialization software offerings

Nearly all US pharma manufacturers have met the requirements of the 2013 Drug Supply Chain Security Act, which required (as of January 2015) the capability to report the lot number of shipments of drugs to trading partners. But only some, market-leading pharma companies are taking the next step: producing reporting data on individual packages of products—aka item-level serialization. Eventually, all will have to be compliant, with manufacturers producing the serialized product by November 2017, and reporting it out to trading partners (wholesalers, retail pharmacies) in later years. It’s a major, billion-dollar investment by the industry, which is also striving for compliance with similar rules from the European Union, Brazil, South Korea and other countries in roughly the same time frame.

Two of the software vendors who have been operating for years in this space—rfXcel (San Ramon, CA) and Covectra (Westborough, MA)—have updated their IT offerings to meet the DSCSA requirements at the item level. rfXcel’s, version 5.6 of its Traceability System, performs the basic functions of generating serial numbers, passing them to packaging line equipment, and then collecting the as-printed data. The industry is gradually coalescing around the EPCIS standard for this item-level data, defined by the GS1 organization. A key part of this is working out so-called parent-child relationships—the aggregations of many individual packages (each with a unique code) into cartons that have their own code. Version 5.6 enhancements include “smart logic” to parse barcode information pertaining to lot, item and other data fields accurately, and an interface to work with Advanced Shipping Notice (ASN) data—an existing methodology for tracking shipments. “We’re going to be working with a mixed, heterogeneous ASN/EPCIS environment for years to come,” notes Glen Abood, CEO of rfXcel.

Covectra’s system, branded at AT Prime, also performs the basic number generation, coding and data-collection actions; the company promotes its compatibility with the EU standards known as the Falsified Medicines Directive; has a European office, and is unveiling AT Prime at Pharma Pack Europe (Paris, Feb. 10-11). The company has put an emphasis on counterfeit detection with its software; a related offering, called AuthentiTrack, is available for this purpose. “AT Prime was developed to adapt to evolving serialization compliance roll-outs, offering a practical, low cost solution, which increases visibility and control and can be deployed quickly and efficiently to serialize the units of trade to enable track and trace and deter counterfeiting,” says Steve Wood, president.

Both Covectra and rfXcel note that their software is compliant with GS1 standards; Covectra has been certified for the EPCIS standard; rfXcel says that its certification is in the works. In addition, rfXcel offers modules tailored to the reporting requirements of China and South Korea; compliance with other countries is being developed.