The management of the cold chain in the biopharmaceutical industry has taken a step forward with the development of the Cold Chain Management Solution (CCMS), a tool designed by Fusion Consulting in collaboration with the SAP Life Sciences team. Built on the SAP Business Technology Platform (SAP BTP), this solution addresses key challenges in preserving temperature-sensitive products such as medications and vaccines, ensuring their integrity from production to patient.
A Critical Issue for the Industry
Cold chain management is essential to avoid economic losses and ensure patient safety. According to the World Health Organization (WHO), 50% of vaccines lose effectiveness by the time they reach their destination due to uncontrolled temperature fluctuations. This not only poses a health risk but also has a significant environmental impact, as every damaged product represents a waste of resources, energy, and materials.
In economic terms, cold chain failures result in estimated global losses of $35 billion annually, according to data from the biopharmaceutical sector. International regulations, such as those from the U.S. Food and Drug Administration (FDA) and the EU Good Distribution Practice guidelines, set strict standards for handling temperature-sensitive products, increasing pressure on companies to innovate their processes.
Fusion CCMS: A Comprehensive Solution
The CCMS solution digitalizes the management of time out of refrigeration (TOR) and time in refrigeration (TIR), two critical parameters for ensuring product stability. Before CCMS, companies relied on customized systems, manual processes, and paperwork, which led to errors, inefficiencies, and compliance risks.
Now, through the use of automated workflows and intelligent alerts, CCMS provides complete visibility of temperature conditions throughout the supply chain. This allows for the prevention of deviations and minimizes the risk of losses. The solution also integrates real-time data through RFID and IoT devices, efficiently connecting with SAP systems.
According to Andreas Krummlauf, Vice President of Life Sciences and Health Product Management at SAP, “CCMS exemplifies how collaboration and innovation on SAP BTP can address critical industry challenges, enhancing patient safety and reducing environmental impact.”
Linking to Quality Management
Information about TOR is essential for quality decisions throughout the supply chain, especially in batch release processes. The integration of CCMS with the SAP Batch Release Hub for Life Sciences, also based on SAP BTP, ensures consistency in data and process optimization, strengthening companies’ ability to meet regulatory standards and ensure quality.
Towards a More Sustainable and Innovative Future
The collaboration between Fusion Consulting and SAP lays a foundation for future innovations. Fusion plans to work with a consortium of leading life sciences clients to continuously adapt and enhance the solution according to market needs.
As noted by Fares Zaier, Chief Revenue Officer of Fusion Consulting, “This solution is an example of how expertise and innovation can create a transformative impact in the industry, saving lives and reducing waste.”
With CCMS, the biopharmaceutical industry is poised to tackle current challenges and anticipate future demands, ensuring product efficacy and contributing to a more sustainable world.
via: SAP