Written clinical trials standard operating procedures (SOPs) should be held by every pharmacy, to cover a number of essential points one of which is ‘temperature monitoring and reporting of temperature deviations’.
Regular temperature monitoring of Investigational Medicinal Products (IMP) storage facilities should also be undertaken and records maintained.
All IMP storage areas should be fitted with calibrated temperature monitoring devices that record minimum and maximum temperatures, with a robust system to alert staff if the temperature falls outside of the specified range.
The temperature monitoring devices should also have a valid calibration certificate which needs to be stored and maintained for reference.
Lastly, each pharmacy should have written procedures in place for the actions that need to be taken, when the storage conditions are outside of the specified range.
We appreciate the pain points involved at every stage of Clinical Trials, not least the storage and monitoring of Investigational Medicinal Products. We are here to help you with a Wireless Temperature Monitoring Solution tailored to your exact needs.
Ensure effectiveness of critical control procedures and protocols by eliminating human error and incorrect data, with a secure and robust recording on a fully auditable platform
Access and consolidate data from multiple departments and sites into a central, multi-user reporting platform, for fast-paced management on the move.
Make the most of your budget by investing in automated monitoring rather than paying to replenish valuable stock
INCREASED EFFICIENCY & LABOUR
Optimisation of key resources to increase productivity and quality by automating the mundane task of routine temperature recording
Automated 24/7 monitoring allows you to manage and mitigate product loss, allowing proactive management of your temperature controlled assets
UKAS & ISO 17025
Comark has ISO 17025 & UKAS accredited calibration laboratories and can bring these services to you with our onsite engineers