How about a free, open-source, DSCSA-compliant traceability system?

While the focus of laggard pharma packagers these days is to get their packaging lines into conformance with the looming November 2018 deadline for having barcoded, item-level serialization of products, companies that have already completed their packaging-line work are now getting their Level 4 (enterprise to enterprise) reporting and tracking systems in place. This Level 4 work is primarily an exercise in software implementation, and there are numerous vendors (TraceLink, SAP, Arvato, Systech, rfXcel and many others) that have built up substantial customer bases for their solutions. Deadlines for systems compliant with the US Drug Supply Chain Security Act (DSCSA) begin in 2019 and continue to 2023 (while in Europe, the Falsified Medicines Directive has a February 2019 deadline).

Now, an under-the-radar effort that started recently among individual software developers is getting a spotlight via Vantage Consulting Group, a New York systems engineering firm that does DSCSA and related IT implementations for pharma. As explained by John Jordon, president, Vantage is not selling software; the system it is promoting is open-source and free. (Vantage is, however, looking forward to assisting packagers and others in implementing this software, as well as most of the other commercially available ones.) “Open source” software is, for the most part, an idealistic undertaking by software developers to create a community that works on building and updating software platforms for the benefit of all. While many open source undertaking are mostly of interest to programmers themselves, there have been several highly successful ones over the years: the Linux operating system and Apache for internet servers are examples.

Jordon concedes that Qu4rtet is, at best, in “beta” stage today; interested users can download the software, perform an implementation, and then aid in refining the software for the types of site servers (which handle Level 2 and 3 communications) that are in the industry today. Among the features being built in are modularization—so that a part of the system, such as for random-number generation, can be adapted alongside a commercial system; and EPCIS version 1.2 compatibility, something that not all current implementations possess. Vantage Consulting, as a member of the Open SCS Consortium, is intent on making Qu4rtet compatible with those evolving standards as well.

The developers working on Qu4rtet come together at a site called Serial-Lab.com; the software itself is available at a related developer’s site, gitlab.com.