Dec 12, 2023
About the Customer
Engineering Industries eXcellence has reached a major milestone in an ongoing transformation initiative for a global innovator in the Pharmaceutical & Life Sciences industry. Headquartered in the United States, our customer researches, develops and distributes antiviral drugs used to treat diseases such as HIV/AIDS, hepatitis, influenza and Covid-19 worldwide. With new drug safety regulations always on the horizon, our customer is taking a proactive approach to compliance that leverages digital technology for future-proof, seamless product serialization, tracking and reporting. The biopharmaceutical leader chose Engineering IndX’s Track & Trace team to help them implement the best solutions to improve safe and efficient production of life-saving medicines and meet emerging regulations in the United States and China.
- Pharmaceutical Manufacturing
- Life Sciences Industry
- Drug Research and Development
- Wholesale Suppliers and Distributors of Pharmaceuticals
- Vaccine Manufacturing
The Customer’s Need
While our customer is committed to creating a healthier world with their innovative medicines, it can be a major challenge to maintain compliance across the different regulatory bodies and complex reporting processes involved. The U.S. Food & Drug Administration’s (FDA) Drug Supply Chain Security Act (DSCSA) and new regulations from China’s National Medical Products Administration (NMPA) will require pharmaceutical enterprises doing business with these countries to enhance visibility of drugs in the supply chain, ensuring validity and enhancing patient safety. With compliance deadlines approaching in 2024, the customer wanted to put in place tracking and tracing solutions that would meet these requirements but also increase their production efficiency, improve visibility of their end-to-end process and create a seamless reporting experience for stakeholders across their supply chain.
- Maintain pharmaceutical compliance across U.S. and Chinese regulatory bodies
- Increase efficiency of pharmaceutical development and production
- Enable end-to-end visibility of the pharmaceutical supply chain
- Create a seamless reporting experience for stakeholders across the Digital Thread
- Deliver safe, authenticated drugs to patients around the world
About the Project
As a long-standing digital transformation partner for this pharmaceutical leader, Engineering IndX’s Track & Trace team was trusted to guide the customer on their journey for efficiency, supply chain visibility and regulatory compliance. This began with our team conducting on-site Digital Supply Chain Assessments at the customer’s U.S. production facilities and working closely with key stakeholders to understand their end-to-end development and distribution processes. Our team identified SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP) as the ideal solution to be integrated with their current digital ecosystem.
Upon approval from the customer, our team began the next phase of the project, implementing and integrating SAP ATTP with their Enterprise Resource Planning (ERP) system, SAP S4/HANA, and preparing the customer for DSCSA and NMPA compliance. Our team’s goal was to create a seamless, automated reporting process that would require as little manual intervention as possible. This involved working with 3rd party logistics (3PL) companies to integrate master and transactional data within ERP and warehouse operations, as well as helping the customer understand country-specific regulatory reporting requirements. As of December 2023, both projects have successfully launched in the United States and China, and our Track & Trace team is currently working on back-end enhancements to bring even more efficiency and visibility to the customer’s drug development.
- Conducted on-site Digital Supply Chain Assessments
- Identified best Track & Trace platform for customer’s unique needs
- Implemented SAP ATTP and integrated with SAP S/4HANA
- Collaborated with 3rd party logistics companies to connect data exchange
- Created a seamless reporting process that relies minimally on manual data input
Engineering’s Expertise
Already supporting 18 out of the 20 largest pharmaceutical companies for their digital supply chain initiatives, Engineering Industries eXcellence is the top global expert in this space, offering roadmap guidance, expert technical knowledge, and broad experience delivering tracking and tracing solutions to manufacturers and downstream partners. As a result, our customers can benefit from increased supply chain visibility along with full regulatory compliance. Acting as the biopharmaceutical leader’s strategic partner on a number of digitalization initiatives, the key to our Track & Trace team’s success was an in-depth understanding of their end-to-end research, development, production and distribution processes. We will continue to support their mission for creating a healthier world by providing the best digital solutions and services in the pharmaceutical industry.
- Long-standing strategic partner for pharmaceutical eXcellence
- Global technology consultant with capabilities for international multi-site delivery
- End-to-end technology implementation and system integration experience
- SAP Gold Partner with niche expertise across their innovative product portfolio
- Vision to support long-term digital transformation
