Case Study: Ensuring Vaccine Integrity with End-to-End Cold Chain Monitoring
Industry: Pharmaceuticals & Healthcare Logistics
Client: A specialized logistics provider responsible for distributing temperature-sensitive vaccines and biologics across North America.
Client Overview
The client's reputation and business depended on maintaining a strict, unbroken cold chain from the pharmaceutical lab to the clinic. Any temperature deviation could render a multi-million dollar shipment useless and put public health at risk. Their existing process involved manual data loggers that had to be physically retrieved and downloaded, meaning temperature excursions were only discovered after the fact, often too late.
The Problem
They needed a proactive, real-time monitoring system that could alert them to potential temperature breaches instantly, allowing them to intervene before a shipment was compromised. They also needed an automated, immutable system for generating FDA compliance reports.
Key Challenges
- Ensuring constant connectivity for shipments traveling through remote areas.
- Providing a validated, 21 CFR Part 11 compliant system for electronic records.
- Integrating with their existing Transportation Management System (TMS).
- Guaranteeing sensor accuracy and reliability for critical medical shipments.
Our Solution
We developed a comprehensive cold chain monitoring solution using cellular IoT sensors that tracked temperature, humidity, light exposure, and shock in real-time. The data was streamed to a secure, validated cloud platform on Microsoft Azure. We built a custom alerting engine that sent SMS and email notifications to the logistics team if any parameter deviated from the pre-set safe range.
- Deployed validated IoT sensors with NIST-traceable calibration certificates.
- Built a secure portal for clients (pharmacies, hospitals) to view the real-time status and history of their shipments.
- Developed an automated reporting module that generated PDF compliance reports with a single click.
- Integrated real-time location and temperature data into their TMS to provide a single view for dispatchers.
99.7%
Reduction in Product Spoilage
75%
Decrease in Time Spent on Audits
100%
FDA Compliance Record