One of the most important aspects of any serialization project is enabling the necessary partner integrations that provide compliance data and (ideally) end-to-end visibility into your supply chain. You need to ensure connectivity to your packaging sites/CMOs, distribution/3PLs, customers and relevant internal systems.
So connectivity is good; it’s vital. But it’s not the goal. You see, connectivity is actually a means to an end.
No doubt you’ve seen serialization vendors touting their 'out-of-the-box integration networks' that are designed to reduce timelines, complexities and costs. Wow, that sounds great, right?
Well, dig a little deeper and you’ll find that there’s much more to achieving successful integrations with your partners. This is not a plug-and-play game; the true driver for success exists in the data collected, created and traded among systems – not the connectivity itself.
Some vendors forget to mention that – they think you’ll be wowed by all these connection points and you’ll neglect to ask the key questions about their integrations. We think this can be misleading, and frankly – a little bit disrespectful of your business needs.
So here are the three most important questions to ask when discussing integrations, connectivity and data insights.
1. Are your integrations built on the GS1 EPCIS standard?
Integration between systems is meaningless if the data standards are not compatible. This is why GS1’s EPCIS is the single-most-adopted method for integration among partners and enterprise serialization systems. EPCIS covers all necessary use cases for pharmaceutical compliance and allows disparate systems to function under the same language.
A majority of out-of-the-box serialization solutions marketed toward pharma don’t actually leverage EPCIS, meaning your systems may be “connected” but they are not actually talking to each other using a common standard. Therefore, as systems or partners change, you may lose the ability to communicate with them. The only way to future-proof and communicate seamlessly is to use integrations that are built using the GS1 EPCIS standard. If your vendor offers you connectivity but dodges this question, you need to take a step back. Ask them to show you proof of EPCIS standards for integrations so you can make an informed decision.
2. Will I be able to customize how I use this data?
You have unique serialization requirements, just like you have unique product offerings and a unique supply chain. But out-of-the-box integrations limit your access to data because they can only deliver a specific set of data in a proprietary way. It can’t accommodate your unique serialization requirements or ensure the necessary level of flexibility you need to ensure value from serialization into the future.
For example, say a biotech company has products with lot-variable potency and wants to include that potency information in a data feed from its CMO partner. With an out-of-the-box integration you can’t add or modify the data set – you get what you get - which limits your ability to report and access data-driven insights. It’s inflexible and it limits your opportunity to gain business value.
But this business value is key. Some vendors may lead you to think that serialization compliance is a one-time project. Implement some software and you’re all set. Even if that was true (which it isn’t) you’d be missing out on huge insights that can benefit your business.
Serialization must be treated as a new business capability and an inherent part of your operational and supply chain management strategy going forward.. You are required to procure and deploy serialization to meet compliance requirements, but why limit yourself? With minimal effort, you can have a much more valuable solution that serves your business far beyond just compliance.
3. How long will each integration actually take and what’s the cost?
The question of cost and timing for serialization is a loaded one because the answer relies on a large number of moving parameters. But, you can break down the costs related to integrations fairly quickly.
Real-world experience in the industry has proven that the resources required to perform the IT integration tasks required between a partner (CMO) and a manufacturer is, in fact, relatively minimal. Consider a typical CMO integration: the majority of the work is focused on modifying quality agreements, business process changes and validation of site-level equipment and processes. With experienced serialization professionals, partner readiness and an advanced enterprise serialization system, the technical components of a CMO integration can be designed and implemented in a matter of days/weeks.
So ask your vendors this: if enabling a connection is such a minimal effort, then why not offer standards-based integrations that benefit the business, and are flexible enough to meet your exact serialization requirements?
Pharma serialization for now and going forward
Look, a good serialization partner isn’t going to nickel and dime you for every integration point or charge you for every serial number used. They understand that connectivity itself is a commodity. The real value is in the data and the insight that connectivity enables. So find a partner that can support your unique data set needs, who offers you future-proofed standards-based integrations and who can show you how to extract the value out of your data. Don’t be afraid to ask the hard questions. It will be worth it - because you should get what you actually pay for.
Michael Howe is chief executive officer of Verify Brand