Tracelink continues to beat a drum about its success in winning business from pharma companies and contract manufacturers who need to meet a variety of product traceability mandates around the world. A press release puts the current client base at 105 companies, a third of which are among the top 50 global pharma firms. Moreover, these clients have compliance requirements in either the US (under the Drug Supply Chain Security Act, DSCSA) or the Falsified Medicines Directive (FMD) of the EU—or both—as well as requirements in India, Brazil, China, South Korea, Turkey, Argentina, Russia and Saudi Arabia. Nearly all of these countries or regions are in the process of requiring a unique serial code to be applied to individual pharma packages, but the reporting and data-collection standards differ from one region to another.
TraceLink chose to make these announcements, it says, on the one-year anniversary of the introduction of the Advanced Track and Trace for Pharmaceuticals (ATTP) platform of SAP, its direct competitor. Multiple other IT vendors have been introducing their own software solutions before and after SAP’s, but it’s clear that from TraceLink’s perspective, the battle for market dominance is between those two. SAP has been relatively quiet about its progress to date, but industry sources say that several dozen pharma companies have signed on (although it’s not clear whether those clients are using ATTP or an earlier SAP solution known as OER). Movilitas Consulting, a systems integrator and SAP solution partner, has announced a cloud-based subscription model of ATTP, which competes with the cloud-only service of TraceLink.
For its part, TraceLink has continued to evolve its platform, now in version 7.3. Most recently, the company has been demonstrating its ability to provision and commission serial numbers at commercial scale (upwards of 9-14,000 read/writes per second), which it attributes to the use of nonSQL database technology. These read/write speeds are not yet a widely recognized industry metric, as most companies are still ramping up their systems simply to carry out the serialization mandates. But in time, they will be essential to maintaining packaging line production and to performing trading-partner verifications of shipments.
The deadline in the US to have verifiable barcodes on packages is November 2017; with trading-partner verification all the way across to retail pharmacies by the early 2020s. Some heavy lifting is in store for the pharma distribution industry between now and then, and TraceLink wants to be your preferred solution provider.