17 Aug 2018
As Clinical Trials protocols become ever more complex so too has the need to provide evidence of data compliance across the supply chain.
The ability to track and trace the entire journey of investigational medicinal product (IMP) is now a fundamental requirement for both good distribution practice (GDP) and good clinical practice (GCP) as regulated by EU GDP Chapter 9: ICH GCP E6.
What does this mean in real terms? Compliant monitoring must be provided for all temperature-controlled material throughout all shipments to active sites. Once located at the investigator sites monitoring must be extended to include its storage whether that’s in a clinical facility or patient home.
The existing model of collecting and manually assessing this essential temperature data often means managing multiple vendors and software applications; it can be resource intensive and time consuming. In turn, it can prove difficult for Sponsors to maintain 100% oversight and confidence that the drug has maintained its labelled temperature.
Thermometers and Temperature Dataloggers can be used across the product lifecycle and collect data in isolation or as part of a live reporting environment.
Standalone dataloggers can measure several factors including temperature and humidity. They connect directly into the USB port of a PC or laptop for set-up and to download the data set collected. The EZ Smart™ range from Woodley Equipment Company comprises of both thermometers and dataloggers with differing capacities.
Alternately, wi-fi enabled temperature monitoring devices can stream, view and record temperature readings via the Cloud, 24/7, 365 days per year. Alarms and alert notifications can be sent by email or SMS message and the data can be accessed remotely.
Woodley also offers a single source temperature monitoring system that harnesses the power of IoT to automate data logging and alert notifications giving you the ability to monitor and manage multiple data logging devices in different locations completely remotely.
The system easily scales to meet your needs. Perfect for everything from compact systems with just a few measuring points to corporate solutions with thousands of devices around the globe.
For more information about temperature monitoring the EZ way please see