Cold Chain Software and Hardware Development Services

A complete, turnkey solution for 3PLs and pharma companies. We design, build, validate, and deploy a GxP-compliant cloud platform that serves as your central compliance hub and single source of truth for all temperature-controlled assets.

Key Features:

• GxP-Validated Cloud Platform
  A fully validated environment built on GAMP 5 principles, ready for your VMP, IQ, OQ, and PQ, ensuring it meets the most rigorous FDA and EMA standards.
• Centralized Monitoring Dashboard
  A real-time command center providing live visibility of all active shipments, storage units, and their environmental conditions, accessible by your team and your clients.
• Product Profile & Alerting Engine
  A sophisticated rules engine that allows you to set specific, multi-stage temperature profiles and alert rules for each unique product or SKU.
• Unalterable Digital Record (ALCOA+)
  Every shipment’s data is captured in a time-stamped log that adheres to ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate).
• Automated Audit & Compliance Reporting
  One-click generation of audit-ready Temperature Journey Reports, Excursion Summaries, and Chain of Custody logs, drastically reducing QA and compliance burdens.

A specialized hardware engineering service for when off-the-shelf loggers don’t meet your needs. We design or pick custom-calibrated environmental sensors (both single-use and reusable) with secure, unalterable GxP-compliant firmware.

Key Service Deliverables:

• NIST-Traceable Sensor Design
  Development of hardware with certified and calibrated temperature, humidity, light, and shock sensors traceable to a National Institute of Standards and Technology (NIST) reference.
• GxP-Compliant Firmware
  Secure, locked-down firmware that prevents data tampering, ensures reliable connectivity, and guarantees data gaps are not created or concealed.
• Custom Form-Factor & Battery Life
  Hardware designed for your specific use case, whether it’s for cryogenic shippers, reusable pallets, or full-truckload monitoring with multi-year battery life.
• Secure Data Transmission & Storage
  End-to-end encryption from the device to the cloud, ensuring data is secure and protected both in-transit and at-rest.

A specialized hardware service for when off-the-shelf loggers fail to meet your GxP or operational needs. We design, validate, and deploy custom cold chain temperature monitoring devices tailored precisely to your high-value assets and supply chain.

Key Service Deliverables:

• NIST-Traceable & Calibrated Sensors
  We deploy certified, high-precision temperature and humidity sensors with NIST-traceable calibration, ensuring your data is scientifically accurate and audit-proof.
• Secure GxP-Compliant Firmware
  Our devices run validated, locked-down firmware that prevents tampering and creates unalterable, ALCOA-compliant data records from the point of capture.
• Custom Form-Factors & Use Cases
  We engineer hardware for your exact needs, including custom enclosures, multi-year battery life, and sensors qualified for extreme cryogenic environments.
• Reliable Data Connectivity
  We configure reliable connectivity to ensure no data gaps, automating the secure flow of sensor data from the device to your cloud platform.
• Full Hardware Validation (IQ/OQ)
  We deliver a complete validation package, including IQ/OQ, to formally document that the devices are qualified and fit for their intended GxP use.

A data engineering service designed to break down information silos. We build robust, two-way integrations that connect your cold chain platform to the core systems that run your business and your clients’ operations.

Key Service Deliverables:

• QMS Integration (Veeva, TrackWise)
  Automatically trigger quality events, CAPAs, and deviations in your Quality Management System based on real-time temperature excursions.
• ERP & WMS Integration (SAP, Oracle, Manhattan)
  Seamlessly associate shipment data with purchase orders, batch numbers, and warehouse locations. Automate inventory release or hold decisions in your WMS/ERP.
• Carrier & Telematics API Aggregation
  Pull in data from carrier APIs and in-vehicle telematics to create a single, enriched record that layers location and asset data with environmental data.
• Client Data-Sharing Portals
  Build secure, branded portals that give your pharmaceutical clients self-service access to the real-time status and compliance reports for their specific shipments.

A standalone data science module that transforms your historical data into actionable intelligence. This module helps you move from reactive monitoring to proactive risk management, optimizing your entire cold chain network.

Key Service Deliverables:

• Lane Risk Assessment Dashboards
  Interactive tools that analyze historical excursion data to identify high-risk shipping lanes, carriers, or packaging configurations that require corrective action.
• Proactive Excursion Warning Models
  AI models that analyze real-time data trends (e.g., subtle temperature drift) to predict a likely excursion before it happens, enabling proactive intervention.
• Thermal Packaging Performance Analysis
  Analyze data to compare the real-world performance of different thermal shippers and packaging solutions, enabling data-driven procurement decisions.
• Carrier & 3PL Performance Scorecards
  Generate automated reports that score your logistics partners on their cold chain performance, providing objective data for QBRs and contract negotiations.