Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that folks don?t like to talk about. Often there is uncertainty about the following: Which software actually should be validated? If so, who should take care of it? Which requirements should be satisfied by validation? How can 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, up to fully automated calibration. Whatever the degree of automation of the program, validation always refers to the complete processes into which the program is integrated. Behind validation, therefore, is the fundamental question of whether the process of calibration fulfills its purpose and whether it achieves all its intended goals, that is to say, does it provide the required functionality with sufficient accuracy?
In order to do validation tests now, you should be aware of two basics of software testing:
Full testing isn’t possible.
Testing is always dependent on the environment.
เกจวัดแรงดันลม that the test of all possible inputs and configurations of an application cannot be performed due to the large number of possible combinations. Depending on the application, the user must always decide which functionality, which configurations and quality features must be prioritised and that are not relevant for him.
Which decision is made, often depends on the second point ? the operating environment of the program. With respect to the application, practically, there are always different requirements and priorities of software use. Additionally, there are customer-specific adjustments to the software, such as regarding the contents of the certificate. But also 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 make it impossible for a manufacturer to check for all your needs of a particular customer.
Correspondingly, considering the aforementioned points, the validation falls onto the user themself. In order to make this technique as efficient as you possibly can, a procedure fitting the next five points is preferred:
The info for typical calibration configurations ought to be thought as ?test sets?.
At regular intervals, typically once a year, but at least after any software update, these test sets should be entered into the software.
The resulting certificates can be weighed against those from the prior version.
Regarding a first validation, a cross-check, e.g. via MS Excel, may take place.
The validation evidence should be documented and archived.
WIKA provides a PDF documentation of the calculations completed in the software.
Note
For more info on our calibration software and calibration laboratories, visit the WIKA website.