Systech, founded in 1985, greeted the new century with an item-level tracking solution in 2000. That was followed by Systech Guardian in 2005, providing Level 4 serialization and data management.
All along the way the company has been enhancing the performance of life sciences packaging lines with machine visions systems, equipment effectiveness systems and, most recently, the UniSecure technology to provide item-level authentication via physical package analysis.
Ara Ohanian, CEO, took the reins of the company in 2017, coming from a background in enterprise software at Infor and CertPoint Systems.
1. Ara, you’re relatively new to the pharma traceability scene; what’s your impression of the industry opportunity here?
When you look at the traceability requirements the industry faces, it is really no different than the enterprise data integrations I’ve dealt with in the past. Pharmaceutical traceability is so interesting because it brings together all elements of the supply chain. There is so much data being exchanged, but little rigor around building value-added analytics around that data.
I see Systech as a leading innovator of providing great value to the overall industry by leveraging this data and operationalizing it. We’ve made strides already with our Systech360 product, which has begun to give customers insight into their operations by leveraging significant sets of previously unused data. We will excel in the industry because of what we can do with the data that is there today, but is not being leveraged.
2. Systech is somewhat unusual among its competitors for having both hardware and software expertise in meeting requirements like DSCSA or FMD. How does this combination benefit its clients, who might prefer a “best of breed” solution for one or the other?
Our big differentiation is the fact that we deliver configurable software, not custom code, to our customers. Being a packaged offering affords our customers seamless and trusted integration between the involved hardware and software systems. Systech projects then are accelerated with our comprehensive portfolio of hundreds of documented implementation modules, which pretty much cover every packaging line scenario we might see. We are as turnkey a serialization solution as you can get in the industry.
3. In recent years, Systech has made a substantial investment in authentication technology, which goes beyond serialization. How has this been received by the pharma industry? Why isn’t serialization enough?
Our authentication solution digitizes and derives a unique e-Fingerprint from the serialized barcode. Though the serialized barcode contains a unique serial number, it is just a printed mark, subject to copy and illicit fabrication. Our digital e-Fingerprint ensures that the authenticated item is truly the original. This has proven to be very powerful with pharmas who have issues with product diversion. Supply chain diversion occurs when there are significant price point differentials between geographies, with product being intentionally moved from lower cost geos into higher cost geos.
Our solution helps several pharmas fight diversion by enabling their field personnel to immediately authenticate items in the field, and with our advanced data capabilities, they can see all the pertinent information for that individual drug package, including its intended destination, and supply chain participants. They will know right then where their supply chain has a break, and know exactly where to go to fix it.
Additionally, the DSCSA and FMD apply to the most secure drug supply chain markets. Our authentication solution is being looked at as a patient protection and anti-counterfeiting measure for geographies that do not have serialization.
With Excellis, we see authentication as a patient protection solution for markets where serialization is not required. Given the rampant counterfeiting in many of these markets, providing an affordable solution that leverages the drug’s existing package and a simple smartphone authentication app is a straightforward way for manufacturers to start protecting their products in these at-risk geographies.
4. Having been at the helm of Systech for a year now, what’s your take on the pharma industry’s approach to adopting technology, meeting compliance requirements, and driving business value? Is the industry an innovator, or a technology follower?
I think I was most surprised by realities of line validation required. You can’t just expect customers to jump when a vendor says “new release!” This has impacted how we deliver and support product significantly. Our customers have taken a very disciplined approach to implementing serialization, and ensuring compliance. Formal serialization cross-functional teams were formed, and a commitment to “repeatability” has been pretty consistently seen. In terms of technology adoption, I believe the industry navigates right down the middle, not an early adopter, but certainly not a laggard. I see the interest in our DSCSA compliance pilot initiatives leveraging blockchain as proof the industry is absolutely willing to embrace cutting edge technology – provided there is a real need, and the technology is proven to work.
5. The industry, and its vendors, are in for a long haul just to get to 2023. Having said that, what’s your vision of how the traceability technology, broadly implemented, will change the industry?
As I said earlier in the interview, it will all be about the data. It isn’t about just tracking and tracing products nor compliance necessarily – it’s about comprehensive visibility based on completeness of a data “vision”. Yes, traceability is implemented, and compliance achieved, but it is truly about the possible analytics based upon that now integrated supply chain funneling data into traceability systems. They can be transformed into active repositories of information that can be mined to better and more comprehensively protect the overall supply chain. This is incredibly exciting stuff.