Client Needs & Relationship
A leading Academic Medical Center (AMC) operates a GMP-compliant cell therapy lab specializing in apheresis-derived and patient-specific cellular products. These therapies are irreplaceable and must be stored under tightly controlled conditions to remain viable and safe. With more than 35 ultra-low temperature freezers holding high-value cellular materials, the lab’s Quality Manager needed a monitoring solution that could ensure FDA compliance, maintain continuous oversight, and provide dependable technical support.
Rees Scientific’s Solution
The AMC selected the Rees Monitoring System as a foundational component of its quality and compliance framework. Validated against FDA 21 CFR Part 11 and 211 requirements, the system delivers secure, traceable data with features such as electronic audit trails, user authentication, and redundancy. It also enables centralized oversight of all freezers, giving the Quality team a single platform for monitoring, reporting, and responding to alerts in real time. Beyond technology, Rees provides 24/7/365 technical support and a responsive regional service team, ensuring fast, knowledgeable assistance whenever issues arise.
Results of the System
With the Rees system in place, the AMC has strengthened compliance, improved data integrity, and achieved efficient monitoring across its large freezer inventory. Centralized reporting streamlines regulatory audits, while continuous oversight minimizes the risk of product loss. Regional field service teams provide peace of mind with rapid, on-site support, allowing the lab to focus on advancing patient-specific therapies without compromising operational continuity.
Key Takeaways
- Rees Monitoring System validated to meet FDA 21 CFR Part 11 and 211 compliance requirements.
- Centralized oversight across 35+ ultra-low temperature freezers.
- Improved efficiency in monitoring, reporting, and audit readiness.
- Continuous support from 24/7 technical help and regional service teams.
- Strengthened confidence in protecting irreplaceable, life-saving therapies.
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