GDP Compliant99.97% Excursion-FreeReal-Time IoT MonitoringFDA 21 CFR Part 211USP Chapter 1EU GDP 2013DSCSA SerializationCell & Gene Therapy Capable−80°C to +25°C Range24/7 Ops CenterGDP Compliant99.97% Excursion-FreeReal-Time IoT MonitoringFDA 21 CFR Part 211USP Chapter 1EU GDP 2013DSCSA SerializationCell & Gene Therapy Capable−80°C to +25°C Range24/7 Ops Center
Cold Chain Assessment
Start with a compliance audit,
not a sales call.
Tell us about your payload profile and facility type. We'll map your cold chain risk exposure and identify GDP documentation gaps — at no charge.
GDP Compliance Checklist
42-point audit checklist aligned with EU GDP 2013/C 343/01 and FDA 21 CFR Part 211 for pharmaceutical transport operations.
- Validated packaging requirements
- Calibration log templates
- Excursion documentation forms
- Driver training checklist
- Backup power verification
- Carrier qualification criteria
Regulatory Alignment
FDA21 CFR Part 211
EUGDP 2013/C 343/01
USPChapter ⟨1⟩ Temperature
PDATR-46 Revised 2024
DSCSASerialization Compliant