Integrating enterprise and control systems in pharma

As regulatory requirements around the world make it increasingly important for drug makers to have in place robust serialization and track and trace capabilities, a number of questions have surfaced regarding automation control. How should data be exchanged from network and enterprise levels down to packaging lines, and how should data make its way back up into the network and enterprise levels?

That question is being addressed by companies includingTraceLink Inc., a provider of software with a global cloud application platform and a company that offers a range of both track and trace and supply network collaboration applications on that platform. Modeled after the ISA-95 standard for the integration of enterprise and control systems, the diagram illustrates some of the line-level and plant-level software implications that need to be considered when building a track-and-trace architecture.

TraceLink has been active in helping a number of pharmaceutical manufacturers develop and implement their serialization strategies around the world. I had a chance to talk with Brian Daleiden, VP Marketing at TraceLink, about some of the challenges that have to be overcome. Highlights:

•Strictly speaking, the Level 5 you see in the diagram isn't really a part of the ISA-95 hierarchy. But it's extremely helpful for pharma manufacturers to keep it in their thoughts as they build out an integration architecture because decisions made at Level 5 can have an impact on what they do on their packaging lines. You have to understand where the serialization and aggregation info will go, what kind of systems may be called on to process that info. Because those systems may have certain requirements, or trading partners may have certain requirements, that may inform how you configure your packaging lines and your site serialization servers and things of that nature.

•The idea of master data management at the enterprise level has become strategically important, particularly at the multinationals where they have to be sure they can push that data to any packaging line in a global enterprise, sometimes to partners such as contract manufacturers, contract packagers, or third-party logistics suppliers, for example.

•Pfizer went live last year with their serialization solution for China. They went from viewing packaging as something done locally for China to something where the requirements are managed globally. They started working with us two years ago to build the infrastructure and then make changes at the packaging line level to support the new approach. It starts with getting the serial numbers from the Chinese government. We capture them and push them down to all the packaging lines. We pull master data from their Pfizer SAP ERP system. And once the products are packaged and moved, we capture those events and push out the necessary reports. Pfizer has done several million units since going live. Might be approaching 10 million units. At our webinar this past spring, two Pfizer representatives talked about this from an operations and IT perspective. It's a matter of rethinking your business. Your architecture has to be set up accordingly. And your operational processes have to be, too. To Pfizer's credit, they were able to re-think manufacturing and supply chain with global harmonization as the key.