Rich of calibration software ? as required by ISO 17025, for example ? is a topic that folks don?t like to talk about. Often there is Unknowingly about the following: Which software actually should be validated? If that’s the case, who should take care of 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 gives 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 refers to the entire processes into that your program is integrated. Behind validation, therefore, is the fundamental question of if the procedure for 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 want 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 an application cannot be performed because of the large numbers of possible combinations. Depending on the application, the user must always decide which functionality, which configurations and quality features should be prioritised and that are not relevant for him.
Which Sneaky is made, often depends on the next point ? the operating environment of the software. Depending on application, practically, you can find always different requirements and priorities of software use. There are also customer-specific adjustments to the program, such as concerning the contents of the certificate. But additionally the average person conditions in the laboratory environment, with a wide range of instruments, generate variance. The wide selection of requirement perspectives and the sheer, endless complexity of the software configurations within the customer-specific application areas therefore ensure it is impossible for a manufacturer to check for all the needs of a specific customer.
Correspondingly, considering the above points, the validation falls onto an individual themself. To make this technique as efficient as possible, a procedure fitting the following five points is preferred:
The data for typical calibration configurations should be defined as ?test sets?.
At regular intervals, typically one per year, but at the very least after any software update, these test sets should be entered into 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, visit the WIKA website.