Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that people don?t like to talk about. Often there is uncertainty about the following: Which software actually must be validated? If that’s the case, who should look after it? Which requirements must be satisfied by validation? How will you do it efficiently and how could it be documented? The following blog post explains the background and provides a recommendation for implementation in five steps.
In a calibration laboratory, software is used, among other things, from supporting the evaluation process, around fully automated calibration. Regardless of the amount of automation of the software, validation always identifies the entire processes into that your program is integrated. Behind validation, therefore, is the fundamental question of if the process of calibration fulfills its purpose and whether it achieves all its intended goals, in other words, does it supply the required functionality with sufficient accuracy?
If you need to do validation tests now, you should be aware of two basics of software testing:
Full testing is not possible.
Testing is always dependent on the environment.
The former states that the test of all possible inputs and configurations of a program cannot be performed as a result of large numbers of possible combinations. Based on the application, the user should always decide which functionality, which configurations and quality features should be prioritised and that are not relevant for him.
Which decision is made, often depends on the next point ? the operating environment of the software. Based on the application, practically, there are always different requirements and priorities of software use. There are also customer-specific adjustments to the program, such as regarding the contents of the certificate. But also the average person conditions in the laboratory environment, with an array of instruments, generate variance. The wide variety of requirement perspectives and the sheer, endless complexity of the software configurations within the customer-specific application areas therefore make it impossible for a manufacturer to check for all the needs of a specific customer.
Correspondingly, considering the above points, the validation falls onto the user themself. To make this process as efficient as you possibly can, a procedure fitting the following five points is preferred:
The data for typical calibration configurations should be defined as ?test sets?.
At Luxurious , typically one per year, but at least after any software update, these test sets should be entered in to the software.
The resulting certificates could be weighed against those from the previous version.
In the case of a first validation, a cross-check, e.g. via MS Excel, can take place.
The validation evidence should be documented and archived.
WIKA provides a PDF documentation of the calculations carried out in the software.
Note
For further information on our calibration software and calibration laboratories, go to the WIKA website.