When one of the world’s largest generic pharmaceutical manufacturers needed a better way to manage global compliance, we answered the call. This industry leader plays a critical role in enabling access to essential medicines across Europe, North America and the Middle East, and they are well-known for their extensive portfolio of affordable treatments. To enable a large volume of life-saving medicines to move through their highly regulated and constantly evolving supply chain, the pharmaceutical leader sought the help of Engineering IndX’s Track & Trace specialists.
The Customer’s Need
Like many pharmaceutical enterprises, our customer faced growing pressure to meet regulatory mandates without disrupting daily operations. The drug developer needed a system that could handle massive volumes of serialized product data and still adapt to their unique distribution setup. However, managing serialization requirements across different markets — from the U.S. Drug Supply Chain Security Act (DSCSA) to the EU’s Falsified Medicines Directive (FMD) — was not just about having the right tools. It required a deep understanding of regulatory processes, supply chain complexity and how to adapt global systems to local workflows. Having already selected SAP Advanced Track & Trace for Pharmaceuticals (SAP ATTP) as their ideal serialization platform, the customer tasked IndX with managing the transition between technologies and ensuring their new system integrated smoothly into existing operations.
- Manage enterprise transition to SAP ATTP serialization platform
- Navigate multiple regulatory environments with different reporting needs
- Integrate serialization processes without slowing down production
- Create end-to-end visibility from packaging lines to pharmacy counters
- Align technology with business workflows, not the other way around
About the Project
This serialization project began in the late 2010s when SAP brought in IndX as a subject matter expert to support the pharmaceutical leader. At that time, the global deployment of SAP ATTP was one of the first in the world. Early on, it became clear that the customer needed more than technical support; They needed a dedicated partner who could tailor serialization to their unique worldwide operations.
Our Track & Trace experts began by taking a deep dive into the customer’s business processes. We worked closely with internal stakeholders to map out how products moved through their packaging, warehousing and distribution flows, and to understand how their regulatory data could most efficiently be captured and shared across markets. This understanding became the foundation for everything that followed.
From there, we led the configuration and implementation of SAP ATTP across their operations, aligning the system with business workflows rather than forcing the business to adapt to the tool. We delivered both functional and technical consulting, along with architectural guidance to ensure long-term scalability. Because our work spanned multiple markets, including the North America, Europe and the Middle East, we designed the system to accommodate varying regulatory requirements while maintaining a consistent global framework.
As the project evolved, so did our responsibilities. We are now creating entirely new business processes to support serialization from secondary packaging to point-of-dispense. Our specialists are developing bespoke reporting capabilities to meet national and regional compliance standards, helping the customer report serialized data to external regulatory bodies with confidence. In parallel, we are integrating SAP ATTP with SAP ERP Central Component (SAP ECC), SAP Warehouse Management (SAP WM) and the customer’s Manufacturing Execution System (MES), enabling traceability and data synchronization across their digital supply chain.
The final result will not just a compliant system, but a well-orchestrated solution that works with the customer’s existing infrastructure. Every enhancement, every integration and every workflow is built to reduce friction, support efficiency and prepare for the next wave of compliance demands. With workstreams still underway and regulatory updates on the horizon, our collaboration continues, guided by the same goal we started with: turning complexity into clarity.
- Launched one of the world’s first global SAP ATTP deployments in partnership with SAP, setting the foundation for enterprise-wide pharmaceutical serialization
- Mapped complex packaging, warehousing and distribution processes to tailor serialization around real-world operations and regulatory data flows
- Configured and implemented SAP ATTP across multiple markets, delivering scalable architecture and aligning system logic with business workflows
- Developed new business processes and bespoke reporting capabilities to meet country-specific compliance requirements and enable confident data exchange
- Integrated SAP ATTP with SAP ECC, SAP WM and MES systems to ensure full traceability and synchronization across the customer’s digital supply chain
