Automate your GMP/GDP compliant mapping report generation
Temperature mapping of new and existing storage facilities is required regularly in order to ensure safe and compliant storages of medicines and vaccines. Retrieving temperature data from all data loggers used during temperature mapping and generating the mapping reports in a compliant way normally involves a lot of skilled manual handling. It can be very time consuming and costly.
AntTail has solved this problem for you. Wireless sensors that are placed in your storage facility can be combined in one or more groups to reflect different storage areas. Data collection and generation of the compliant mapping report is completely automated and available in minutes.
Wireless Data Collection
Big advantage of using wireless sensors is that you can leave them in place and still have the data and generate mapping reports. The AntTail sensors use a Bluetooth protocol to communicate to our AntCloud where all sensor data is collected and the mapping report is generated. You can choose for on-line or off-line monitoring. You can follow your storage area temperatures directly online in the AntCloud portal. For on-line connection you need one or more gateways depending on the layout and size of the storage areas. For off-line use the sensors can be synced quickly and easily to the AntCloud by a smartphone using our AntTail App.
Generating a Mapping report
When the temperature data is in the AntCloud, generating a mapping report and signed data exports is a just few clicks away. You choose the time period and the temperature limits you want to use and press GO. A few seconds later the email is dropped in your inbox with the generated mapping report and secured data exports in one .zip file.
Mapping report features
Mapping report according to: WHO Temperature mapping of storage areas, Annex 9, No. 961-2014 o Maximum and minimum for each sensor.
Average or Mean Kinetic Temperature for each sensor.
Hot and Cold spots for each monitor area/ group of sensors.
Flexible time period definition: from hours up to 7 days.
Flexible temperature limits.
No need to consolidate data over all sensors. Direct result for a group of mapping sensors.
Every temperature-sensor export is secured by a hash signature. No more manual validation and signing of each data export necessary.
All secured data exports and the pdf are stored in one .zip file that is emailed to the user. All results available within minutes.
References to calibration certificates included in the mapping report and certificates included in the zip file
See how easy it is to generate a mapping report at: AntTail Continuous Mapping Video
Typical location of data loggers in a pallet racking storage area
(Example from WHO: Temperature mapping of storage areas, Annex 9, No. 961-2014)
Efficient Mapping Process
AntTail’s mapping service with easy read out of sensors and fast, automated report generation allows for an efficient and iterative mapping process during your storage qualification. If the first mapping result is not compliant during e.g. IQ, no need to re-install all the sensors. Adjust your heating/cooling equipment and go for a second run, or a third or use all the sensors to get the cooling and heating equipment adjusted to the correct settings.
Sensors can also be left in place after OQ/PQ for summer and winter mapping or continuous mapping.
Convert Mapping in to Monitoring
After the mapping has been completed, the Cold and Hot spot sensors can be converted to on-line monitoring sensors with an alarm profile and notification settings. This requires a license fee from AntTail but the sensors can stay in place and perform in the new role as required.
Consultancy and Rental option
AntTail can help you determine the location and the number of sensors according to the WHO regulations. Send us your questions and we get in touch with you.
For mapping, AntTail also provides a rental option for sensors with calibration certificates.
Quote from Pharma Project Manager, responsible for realization of new cold store for 5000 pallet places that required over 250 sensors for mapping: ” Which for me has a great added value of the AntTail system, that you can perform qualifying runs as often as you want, without having to remove the sensors and download them. And that you have a real-time image of your mapping, which is also very useful for adjustment.”
Interested in a Quick and Easy Solution?
Are you interested to see how the automated generated mapping report and data export looks? Visit https://AntTail.net/mappingexample and download an example mapping report and data export zip file directly. For further information please get in touch with AntTail at firstname.lastname@example.org
AntTail provides transparancy in the supply chain. AntTail designs and delivers products and services that monitor the temperature of medicine during transport and storage from manufacturer to end user. Smart sensors allow pharmaceutical companies, health providers and logistic service providers to monitor the temperature of shipments online and assure product quality. AntTails cloud based secure SaaS-solution works with existing cold chain solutions, avoiding investments and complex implementations. For more information: email@example.com or www.anttail.com