FOR PHARMACEUTICAL & BIOTECH OPERATIONS
Cold chain integrity from production to patient.
GDP-compliant temperature monitoring for pharmaceutical manufacturing, distribution, and last-mile delivery — built around the regulatory environments that govern your supply chain.
A complete cold chain partnership
OPERATIONAL RISK
Temperature excursions cost the industry billions every year.
- WHO estimates 25% of vaccines arrive degraded due to cold chain failures.
- Pharma temperature deviations trigger product holds and recall costs averaging $10M+ per incident.
- Manual log spreadsheets fail FDA 21 CFR Part 11 audits.
WHAT YOUR TEAM NEEDS
Continuous, audit-ready visibility — without adding headcount.
- Real-time alerts before product reaches the threshold of damage.
- Tamper-proof records that satisfy FDA, EMA, MHRA, and PMDA inspectors.
- Integration with your existing ERP, WMS, and quality systems.
A complete cold chain partnership
01 · HARDWARE
Dataloggers and gateways engineered for pharmaceutical environments — −200°C to +150°C, validated to your protocols.
02 · ZTMS CLOUD
Real-time dashboards, automated GDP/Part 11 reports, REST API into your QMS, ERP, and WMS.
03 · REGIONAL SUPPORT
Dedicated specialists in San Francisco and Düsseldorf. Validation support, deployment, and audit assistance.
Compliance standards we support for pharmaceutical operations
Each ZKSCool deployment includes IQ/OQ/PQ validation documentation, calibration certificates traceable to NIST/PTB standards, and audit trail exports compliant with FDA 21 CFR Part 11 and EU GDP §6.
CASE STUDY · PHARMACEUTICAL DISTRIBUTOR
How a top-10 US pharma distributor cut temperature excursions by 40% in one quarter
Deployed 2,400 S6K dataloggers and 80 G20 gateways across 14 distribution centers. Replaced 3 incumbent vendors with a single integrated zTMS dashboard.
−40%
Excursions
14
DC’s deployed
0
FDA findings
2,000+
Pharma enterprises served
600+
Blood stations
99%
Temperature accuracy
60+
Countries
Questions pharmaceutical buyers ask us
Yes. We provide IQ/OQ/PQ documentation and support customer-specific validation protocols. Calibration is NIST/PTB traceable.
REST API and webhook events for real-time integration with major QMS platforms. Pre-built connectors for SAP and Oracle. Custom integrations supported by our regional engineering teams.
Regional hosting available — EU data stays in EU (Frankfurt), US data in US-East. SOC 2 Type II certified data centers.
Talk to a pharmaceutical cold chain specialist
1-business-day response · IQ/OQ/PQ documentation included · Validation support from our SF and Düsseldorf teams