As part of validation of cold chain management systems, the temperature monitoring systems of the cold chain need to be validated as well.
What is validation?
Validation is the process of validating the measurement and monitoring devices used for monitoring temperature and humidity. This is generally done as per the guidelines of 21 CFR Part 11. The process ensures that the measurement and recording of data is done correctly.
What is validation of wireless temperature monitoring?
In a wireless temperature monitoring system, the parameters to be validated are the following:
- Is the hardware (wireless data collection and transmission unit) collecting data correctly?
- Is the reading collected by the software correctly?
- Is the data transmitted correctly through wireless?
- Is the data stored in a local network or cloud based network correctly?
- Is the data displayed correctly?
In a nutshell the entire process of data collection and storage has to be validated to ensure that the electronic measurement system is dependable for collection and storage of the data
What is Protocol for validation of temperature monitoring systems?
The validation is done as a whole system including hardware and software. The validation protocol will consist of the following:
a. Installation Qualification
The installation qualification will involve the following:
- Meeting all requirements of installation in a computer
- Providing various admin rights and user rights to various users as per the design of the software
- Providing passwords as per the design and verification that the same are working correctly in the software
- Define and check each and every function of the software
- Check access levels of all users as defined in the software
b. Operational Qualification
Operational qualification as part of validation involves verifying all parameters during the operations (normal functioning). This includes mainly the following:
- Data accuracy verification
- Verifying all alerts generated by the software
- Verifying all other buttons such as record, stop, reset etc. related to functioning of the recording system
- The accounts and relevant permission of each user to be verified to ensure that it is performing as intended
- Audit trail account verification
- Audit trail accuracy verification
The whole process involves verification of numerous parameters and recording the data in certain formats and checklists as per the protocol for wireless temperature monitoring or any other system under qualification.
For preparation of a protocol, all details of the software and hardware are required so that the protocol reflect all the details. The protocol for each set of devices and software will be different based on the functions of each of them.
Also please see our article on temperature mapping study & validation of cold rooms, warehouses, active/passive boxes.