Qu4rtet, an IT solution for Level 4 compliance with the Drug Supply Chain Security Act (DSCSA), has a first publicly-announced commercial user: Sovereign Pharmaceuticals, a Fort Worth, TX, developer of generic products and 505(b)2 submissions. Since literally hundreds of manufacturers, and thousands of distributors and pharmacies (eventually) will need to have some software implementation for DSCSA compliance, the Sovereign announcement is not a turning point by any means–but it does have implications for how the next few years of DSCSA compliance will play out.
Over the past decade, a growing number of vendors, led by TraceLink, have developed solutions to manage the flow of serialization data from packaging lines (where individual identifiers are applied to each pharmaceutical package) to the enterprise, and from thence to trading partners and data repositories where tracking data can be shared. (In the US, the industry is currently on a march toward a November deadline for being able to authenticate salable returns by their serial data.) Qu4rtet is the first and perhaps only solution that is open-source–no license is needed and the software is available for download; nor are there per-use charges.
According to Vantage Solutions, an IT services company, Sovereign is not the first commercial user; “Vantage has successfully completed projects with other companies as well.” In this regard, Vantage is following the model of other open-source projects: service providers make a living from implementing the software, not from selling licenses for it. Vantage announced the availability of Qu4rtet about 16 months ago; one of its developers, Rob McGee, has also written about the current complexities in DSCSA software implementation.
So, while any pharma company could opt for the no-cost software, they are dependent on the community of developers and service providers to maintain the software–a not insubstantial risk. On the other hand, there have been more than a couple vendors in the DSCSA space that have gone out of business over the past decade, leaving their clients with little recourse. Furthermore, according to at least one expert in the field, DSCSA compliance will require users to rip out their existing software in the next few years and replace it with new software. Already, there is a substantial movement toward adopting blockchain technology for Level 4 compliance, and at least one vendor, Chronicled, has announced an out-of-the-box, blockchain-based solution for salable returns.