As part of validation of cold chain management systems, the temperature monitoring systems of the cold chain need to be validated as well.
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.
In a wireless temperature monitoring system, the parameters to be validated are the following:
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
The validation is done as a whole system including hardware and software. The validation protocol will consist of the following:
The installation qualification will involve the following:
Operational qualification as part of validation involves verifying all parameters during the operations (normal functioning). This includes mainly the following:
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.\
We, at vackerglobal, provide many other warehouse and air engineering solutions. Please visit our website for the details.
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What about PQ stage?
This is good work. Can I get a complete template protocol for validating wireless sensors?.
The document is our proprietary. You may contact our office for further assistance.
Can i get sample of validation study of a cold sorage reefer van ,
Dear sir/Madam,
Can I get a complete template protocol for validating wireless sensors?.
lot of thanks in advance