Regulation of the pharmaceutical industry is evolving rapidly as an increase in temperature-sensitive products enter the supply chain.


PROBLEM

  • Numerous touch points exist between producers and consumers, each of which creates a risk of temperature-sensitive products becoming adulterated
  • Supply chains currently lack instantaneous, continuous and transparent data relating to cold chain maintenance, resulting in regulatory non-compliance, inability to take timely corrective actions, increased liability, loss of product efficacy, and product destruction.

OUR SOLUTION

  • Low cost, disposable sensors provide temperature monitoring  with automatic alerts and continuous visibility
  • Technology and products are easily deployable via Smartphone and NFC communication

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FEATURES

  • Innovative hardware that can monitor shipments from manufacturing to the last mile.
  • Cloud-based software platform for instant, global access to temperature data.
  • Temperature data can be downloaded for instant viewing via a mobile phone or any other device with NFC reading capability
  • Enables integration with ERP and supply chain solutions
  • Designed to achieve regulatory compliance, including 21 CFR Part 11

The Chronicled Temperature Logger is a next-generation solution created to solve the unique needs of the life science cold chain.

 

NFC Temperature Logger

Overview

The NFC Temperature Logger is a low-cost, disposable, portable, smart sensor that tracks and stores temperature readings.

When used together with the Chronicled platform and blockchain back-end, the NFC Temperature Logger delivers end-to-end data security.

Hardware Features

  • Ultra-thin adhesive form factor

  • Near Field Communication (NFC) enabled for common Android phones and devices with NFC reading capability
  • Regulatory compliance by design, including CFR 21 Part 11
  • Position tracking
  • Temperature range: -20 to 50°C (-22 to 122°F)
  • Log capacity for more than 10,000 temperature records
  • Configurable parameters, including sampling frequency, min and max temperature
  • Thin flexible battery with more than 120 days of life after activation
  • Optional customized artwork
  • Temperature calibration according to ISO/IEC 17025

PLATFORM

Overview

The turnkey Platform for Smart Supply Chain and Temperature Sensing that meets compliance and consumer demands on cold chains today and prepares you for the future

Web Dashboard Features

  • Cloud-based Web Dashboard: immediate worldwide permissioned access to complete temperature data via web browser
  • Downloaded temperature data is secure and immediately viewable in the Cloud via a personalized web display. 
  • Large scale implementations supported via IoT gateways
  • Integration with ERP and supply chain solutions
  • Blockchain support via open sourced SDK and Chronicled API
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Mobile Application

  • Near Field Communication (NFC):  application-driven via cell phone or NFC reader
  • View temperature logs at preset intervals, graphic summaries, and if temperature bounds have been maintained throughout a journey through the supply chain.
  • Customizable Configuration
  • Device Activation
  • View Temperature Logs at Preset Intervals
  • Download Temperature Log
  • Graphic Summaries
  • Instant notification of temperature excursions via text message / email
  • Last mile visibility
  • 21 CFR part 11 Compliant

Watch the Workflow


Success Stories

 
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NFC Temperature Logger Field Test

In August of 2017, Chronicled started to deploy its NFC Temperature Logger in a UAE-based distribution facility for a big ten pharmaceutical brand. The Chronicled NFC Temperature Logger was deployed alongside existing market solutions and performed superiorly. 

Currently, temperature monitoring devices are large, expensive, data is not always accessible, and there is no way to certify the readings. This results in non-compliance, increased liability, loss of product and dollars, and potentially loss of life.

Chronicled's Temperature Logger technology can be affixed to packaged goods or included in cold boxes. This provides low-cost temperature tracking at every touch point between producer and consumer, and allows smartphone notifications if temperature excursions occur.
 
The technology platform is production ready and 21 CFR Part 11 regulatory compliance is in place.  The platform can be easily integrated with existing ERP, supply chain solutions, and data lake solutions.