The battleground for IT solutions to meet the requirements of the Drug Supply Chain Security Act (DSCSA), as well as similar traceability regulations coming into force around the world, is heating up. On Sept. 15, SAP formally launched ATTP, propelled by a collaboration with nine of the top 20 pharma companies and a major US wholesaler. The software enables pharma manufacturers to generate serial numbers (random ones if desired), transmit those serial codes to packaging lines, and then track the disposition of the coded unit products into warehousing and out to trading partners. For several years, SAP has offered a two-part solution, known by its acronyms AII and OER, to accomplish much of this activity, but that software is limited in its reporting capabilities and complexity to install. Pharma manufacturers—some of whom are already live with AII/OER solutions—will now consider the new software as a means of meeting the DSCSA requirement for unit serialization in late 2017.
SAP Life Sciences had set up a customer network that worked for the past two years on scoping out ATTP. “We went on a very exciting journey together with one team of SAP experts and industry representatives collaborating toward the same goal,” said Stéphane Aubert, director of IT, Serialization Program & CMO Integration, UCB BioPharma. “With SAP Advanced Track and Trace for Pharmaceuticals, we have a solution designed to fulfil our requirements.”
Tracelink (North Reading, MA) is shaping up as the most direct competitor to SAP’s marketing push. The day after the SAP announcement, Tracelink announced an “SAP Migration Kit” specifically to handle AII/OER migrations to Tracelink’s Life Sciences Cloud, its method to link serial data information at a manufacturer to downstream trading partners. Manufacturers, said Shabbir Dahod, Tracelink CEO, “are concerned about moving to a new product that isn’t market-tested, and the risk of not being able to meet critical serialization deadlines in time.” TraceLink “has already completed successful AII and OER migrations to the Life Sciences Cloud for multiple global pharma companies, all of which were live, in production, in just a few months,” he said in a statement.
And in the week prior, TraceLink updated its client base data: Sixteen of the top 20 global pharma companies, and all five of the top biotech makers, are using TraceLink; its Life Sciences Cloud has processed 2.27 billion transactions to date, and nearly 200,000 manufacturers, distributors and dispensers are registered. TraceLink’s philosophy has been to enable an easy onboarding process—setting up an account in its network—and then working with account owners to install the tracking and reporting software necessary for regulatory compliance. It says it also has 15 “out of the box” solutions for meeting the specific national requirements of, among others, the US, Brazil, China, India and South Korea.
For its part, SAP’s ATTP is compliance-ready for the US, China, Turkey and Argentina; Brazil, South Korea and India are expected next. However, SAP insiders say that compliance with Brazil (as one instance) is not possible as yet because the regulations are still being finalized in that country.
Go to the cloud
To some degree, the traceability task is shifting to how best to utilize cloud-based services; the data generated by serialization processes is massive, and providing ready access to a specific set of numbers (to identify, as an example, suspect or counterfeit product on the fly) is a challenge. TraceLink has been very up-front with promoting its relationship with Amazon Web Services (and the data-access and —security tools available thereby). At the ATTP introduction, SAP representatives raised the idea of setting up a “Pharma Network” modeled somewhat on an existing SAP offering, the SAP Financial Services Network, which uses SAP’s own cloud infrastructure to enable organizations to manage their transactions with diverse banking establishments. A key part to both ATTP and this potential network is HANA, SAP’s high-performance database-management software, now in use at many SAP clients. ATTP clients who also deploy HANA will have an easy integration process, but ATTP is also set up to work with non-SAP tools and software.
In the broader sense, SAP and TraceLink is an apples-to-oranges comparison; their solutions are organized around different goals, and it will likely be possible for both to be installed at pharma companies and their business partners. And both make accommodations for other parts of the traceability task: managing packaging line activity, warehousing and regulatory reporting. There are multiple other vendors handling one or another part of the overall system. For now, there’s some comfort that global-scale IT systems are becoming available from multiple sources, and ahead of the deadlines in much of the world.