For Pharma & 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.
OPERATIONAL RISK
Temperature excursions cost the industry billions every year.
- ~20% of temperature-sensitive healthcare products are damaged or degraded during distribution due to poor cold chain management. (eawlogistics.com)
- ~$34 billion in annual biopharma losses attributed to supply-chain temperature failures. (eawlogistics.com)
- Cell & gene therapy cold chain logistics market: $2.27B (2025) → $16.95B by 2035 (Towards Healthcare 2026).
What your team needs
Real-time visibility, tamper-resistant records, one vendor across the stack.
- Real-time temperature, humidity, and location visibility — surfaced as alerts to email, SMS, or your existing TMS, QMS, or ERP.
- Tamper-resistant PDF and CSV exports compatible with 21 CFR Part 11 and EU Annex 11 electronic records standards.
- One-stop validation service — GSP globally available; GxP and IQ/OQ/PQ in selected countries.
Our approach
A complete cold chain partnership.
01 · Hardware
Dataloggers and gateways engineered for pharma environments — PT100 cryogenic to ambient, validated to your protocols.
02 · zTMS Cloud
Real-time dashboards, audit-trail-ready records aligned to 21 CFR Part 11 / EU Annex 11, REST API into your QMS / ERP / LIMS.
03 · Regional Support
Local team in San Francisco, partner network across Europe, R&D and engineering in Shenzhen. Validation service in selected countries.
Recommended products
Four products that fit this industry’s scenario.
S6SA Datalogger
PT100 cryogenic · door + light + vibration · 30 days
Why for this industry: Audit-grade flagship for CGT, ULT freezers, GMP cabinets.
S20 Datalogger
3 channels · PT100 cryogenic · 4G + WiFi + LBS
Why for this industry: Operator-driven transport with on-device PDF + Flight Mode for depot and air-cargo handling.
S6K Datalogger
2-inch TFT · 4-button · on-device PDF + Bluetooth print
Why for this industry: Operator-facing for blood bank, dispensary, in-vehicle workflows where the workflow happens at the device.
G20 5G IoT Gateway
5G + 4G + NB-IoT + WiFi + LoRa + 485 · built-in sensing
Why for this industry: One gateway hardware ships across manufacturing, distribution, and transport — single ops platform.
Compliance
Designed to support the standards this industry operates under.
GSP — globally available
21 CFR Part 11 design alignment
EU Annex 11 design alignment
GDP-aligned
ISO 17025 traceable calibration
ISO 9001 · 14001 · 45001 · 27001 · 20000-1 (company)
Our one-stop validation service offers GSP qualification globally and GxP / IQ/OQ/PQ qualification packages in selected countries — scoped per customer environment.
CASE STUDY · PHARMA COLD-CHAIN LOGISTICS
Keeping the chain unbroken from warehouse to last-mile delivery
SF Pharma and JD Cold Chain — two of China’s leading pharmaceutical carriers — needed to prove temperature integrity on long-haul routes where legacy loggers only exported data after the trip, too late to act on an excursion. ZKSCool deployed S20 loggers for real-time 4G upload, G20 loggers running interBow® kilometer-range wireless across refrigerated fleets, and the ZKSCool® Biosafety Transport Box with onboard AIoT temperature control, vibration, acceleration and open-box monitoring. Every shipment now streams live to the cloud — pairing GPS location with temperature for end-to-end “where is it / how cold is it” visibility, aligned to GB/T 46204-2025 and NMPA electronic-traceability requirements.
Real-time
In-transit cloud upload
GPS + T
Flow + temp dual traceability
Km-range
interBow® fleet coverage
Where we are
60+
Countries served
500K+
Cold chain nodes monitored
5
Active ISO certifications
10 yr
Cold chain IoT experience
Frequently asked
Questions this industry asks us.
EU GDP guidelines mandate continuous or periodic monitoring with alarm systems and audit-trail-ready records. Modern interpretations require electronic records that meet 21 CFR Part 11 / EU Annex 11 — tamper-resistant, time-stamped, retrievable for the full retention period.
The zTMS Cloud platform is designed around electronic-records principles: tamper-resistant PDF and CSV exports, raw data immutable, automatic audit-trail capture, role-based access controls. Final qualification depends on your validation scope — our one-stop validation service in selected countries scopes IQ/OQ/PQ to your environment.
Yes — autologous patient-specific CGT therapies typically require cryogenic transport at −80°C to −196°C. ZKSCool S20, S6K, and S6SA dataloggers all offer an optional PT100 cryogenic probe with a −200°C to +150°C operating range.
Five active company-level ISO certifications: ISO 9001:2015 (until 2027-05-14), ISO 14001:2015 (until 2028-01-22), ISO 45001:2018 (until 2028-01-22), ISO/IEC 27001:2022 (until 2028-04-28), and ISO/IEC 20000-1:2018 (until 2028-04-24).
Yes. zTMS exposes a REST API and webhook events for SAP, Oracle, Veeva, MasterControl, TrackWise, and major QMS / ERP / LIMS platforms.
Talk to a pharma cold chain specialist
Reply within 1 business day · Validation package on request · Sample units available for qualified pilots