Sep 14, 2023
About the Customer
Engineering Industries eXcellence’s supply chain traceability team has successfully implemented extended tracking and tracing capabilities for a long-standing customer and one of the largest companies in the Pharmaceuticals & Life Sciences industry. Headquartered in Germany, our customer specializes in the global manufacture of medicines for respiratory and central nervous system diseases, metabolism, immunology and oncology. Thanks to this successful initiative, the customer and their main distributors in the U.S. will now be compliant with new federal regulations in North America, ensuring that their business can continue to operate at full speed and that patients can get life-saving drugs.
- Pharmaceuticals & Life Sciences
- Drug Research & Development
- Pharmaceutical Manufacturing
- Global Pharmaceutical Distribution
- Specialized Healthcare
Customer Background
Engineering Industries eXcellence has been working with this customer for many years, delivering solutions and expert services focused on helping them evolve along with pharmaceutical needs and regulations around the world. In the past, we have supported the implementation and integration of track and trace solutions covering North America and Asia-Pacific. We began with the successful delivery of serialization and logistics services for their medicines in the China market with a connection to SAP Information Collaboration Hub (SAP ICH). We also provided advanced serialized logistics services in the U.S. market over the years. Due to our unique knowledge of industry-specific requirements and standards, this customer considers us their strategic partner when it comes to supply chain traceability and quality assurance.
The Customer’s Need
Most recently, in the United States, the Food & Drug Administration (FDA) is implementing new industry regulations to protect consumers from counterfeit pharmaceuticals. Known as the Drug Supply Chain Security Act (DSCSA), this multi-faceted regulation will require that drug shipments contain electronic documents detailing all serial numbers, aggregation architectures and purchase order references. Because the customer is headquartered in Europe, they use a third-party distributor in the United States, which adds another layer of complexity to their compliance initiative. As the customer’s strategic digital transformation partner, Engineering IndX was tasked with delivering capabilities for both the customer and their distributors that would ensure DSCSA compliance, protect the supply chain and keep American customers safe.
- Ensure compliance with new FDA requirements in North America
- Protect the customer’s supply chain from counterfeit pharmaceuticals
- Synchronize operations with third-party distributors in the U.S.
- Provide electronic documents with serial numbers, aggregations and reference orders to regulatory authorities
- Manage complexity across the end-to-end pharmaceutical supply chain
About the Project
The customer has previously adopted Engineering IndX’s proprietary solution, Movilitas.Cloud, a unique Software-as-a-Service (SaaS) application designed to enhance serialization and product visibility throughout the end-to-end drug lifecycle. As a result, the customer determined that it was the ideal platform for their third-party distributors to facilitate DSCSA-compliant logistics. Our team of track and trace specialists integrated the software-as-a-service solution with the customer’s and distributors’ Enterprise Resource Planning (ERP) systems, SAP ICH and SAP Advanced Track & Trace for Pharmaceuticals (SAP ATTP). As a result of this initiative, our experts delivered the following capabilities:
- Automatic processing of incoming Electronic Product Code Information Services (EPCIS) files
- Automatic creation of outbound deliveries based on incoming files from SAP ICH
- Automatic fetching of master data from the FDA based on incoming files from SAP ICH
- Actions on received items such as hierarchy viewing, unpacking, verification, serial decommissioning and replacing child trade items of parent trade items
- Printing of linear barcodes for aggregations
- Automatic reporting of serial number decommissioning and verification request compliance
- DSCSA-compliant execution of outbound deliveries in the warehouse, including validations, pallet building, adding homogeneous pallets to deliveries and delivery shipping
- Automatic triggering of outgoing Transaction Information/Transaction Statement (TI/TS) in the form of an EPCIS file as per DSCSA requirements after shipping delivery
- Overview of daily deliveries and the capability to export the details into a Microsoft Excel file
- Inventory checking capabilities
Thanks to this successful launch of DSCSA functions in the customer’s North American distribution center, the pharmaceutical leader has facilitated compliance for its biggest wholesale distributors, covering almost 100% of shipments in the U.S. They are now in a comfortable position to add additional customers whenever needed and scale quickly.
Engineering’s Expertise
Engineering Industries eXcellence has strong domain expertise in end-to-end traceability, supply chain visibility and regulatory compliance. As a long-standing strategic partner of the pharmaceutical leader, our experts have driven many successful digital transformation initiatives and cultivated trusting customer relationships based on positive implementation experiences. Not only do we understand the customer’s processes and business environment, but our experts also work side-by-side with them to develop the right roadmap for their Industry 4.0 journey.
- Pharmaceutical industry and supply chain management experience
- Regulatory compliance expertise across regions and industries
- Robust skill sets across track and trace software products
- Global capabilities for multi-site delivery
- Vision to support long-term digital transformation
