The future of the inbound supply chain involves implementing electronic data exchange (EDE), or eData, for streamlined and efficient communication and coordination. eData is the concept for sharing of data in the life science industry. For the inbound supply chain it is primarily focused on sharing of electronic certificates of analysis (eCOA, COA), for assurance of both the quality and consistency of raw materials.

The recent pandemic highlighted the importance of the inbound supply chain for drug manufacturing, with industry groups leading the way in solutions and standardization. Industry collaboration group, BioPhorum developed a Supply Chain Strategic Framework, a five year plan for implementation between 2021 and 2026. Their Supply Partner Phorum (SPP) identified end-to-end digitization as one of five strategic objectives for the inbound supply strategy, recognizing that shared and electronic data exchange is a cornerstone for the collaboration and innovation needed to build in resilience (1).

In their white paper, ’The Future of the Inbound Supply Chain: Implementing Electronic Data Exchange’, BioPhorum advocates the life science industry to utilize standard ASTM 3077-17 for the exchange of XML files between customers and suppliers across the supply chain (1 and 2).

It is clear that digital solutions for the inbound supply chain hold much promise. eData is poised to have a significant positive impact on the biopharmaceutical industry by streamlining processes, improving efficiency, enhancing collaboration, and promoting innovation. There are several ways in which digital delivery of raw material data will change the biopharmaceutical industry and can benefit you. These are through:

  1. Efficient data sharing: Electronic data exchange allows for the rapid and efficient sharing of data among different stakeholders in the biopharmaceutical ecosystem. This speeds up the development and approval of new drugs.
  2. Drug discovery and development: Collaborative platforms and data sharing accelerate drug discovery and development. Researchers can access large datasets and use advanced analytics to identify potential drug candidates and predict their safety and efficacy.
  3. Cost reduction: By eliminating the need for paper-based record-keeping and manual data entry, electronic data exchange can significantly reduce operational costs and the likelihood of errors. It also streamlines administrative processes.
  4. Regulatory compliance: Electronic data exchange helps pharmaceutical companies comply with evolving regulatory requirements. It enables real-time reporting and data submission to regulatory authorities, reducing the time and effort required for approvals and inspections.
  5. Supply chain management: Electronic data exchange optimizes supply chain management by providing real-time visibility of inventory, production, and distribution. This helps reduce the risk of drug shortages and improves overall supply chain efficiency./li>
  6. Data security: As more data is exchanged electronically, robust data security measures become essential to protect sensitive patient information and intellectual property. This will lead to advancements in data encryption, access controls, and cybersecurity in the industry.
  7. AI and machine learning: Electronic data exchange provides the data necessary to fuel AI and machine learning algorithms. These technologies can help identify patterns, predict outcomes, and optimize drug development processes.

 

eData is set to bring about a transformative shift in the biopharmaceutical industry. Its holistic impact will enable faster, more cost-effective drug development and greater collaboration among stakeholders, ultimately leading to the development of more innovative and effective treatments. In the crucial area of procurement and the processing of raw material data as part of the inbound supply chain, it is a solution that champions data integrity compliance, quality and visibility. A solution that takes data such as eCOA and lot genealogy from multiple complex supplier-manufacturer relationships, and digitally bridges the information to your data management system.

Learn about Cytiva's data bridge
  1. Paper, Enriquez C, Wang T, Mack A, Collby D, Zune C, Leonard P, Trevisan A, Flamm E, Dayer V, Wing S, Merrick Ramirez N, Kierans G, Kleinmaier R, Ferreri M, Lebovitz R, Rajamani S, Sloan S, Middleton K, Kilduff A, The Future of the Inbound Supply Chain: Implementing Electronic Data Exchange (EDE), BioPhorum Operation Groups Ltd: November 2022. https://doi.org/10.46220/2022SP004
  2. Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers. ASTM E3077-17, Oct 13, 2017. https://doi.org/10.1520/E3077-17