Vanquish of calibration software ? as required by ISO 17025, for example ? is a topic that folks don?t like to talk about. Often there is uncertainty concerning the following: Which software actually must be validated? If that’s Love , who should look after it? Which requirements must be satisfied by validation? How would you do it efficiently and how is it documented? The following blog post explains the background and gives a recommendation for implementation in five steps.
In a calibration laboratory, software can be used, among other activities, from supporting the evaluation process, up to fully automated calibration. Whatever the degree of automation of the program, validation always identifies the complete processes into which the program is integrated. Behind validation, therefore, may be the fundamental question of if the procedure for calibration fulfills its purpose and whether it achieves all its intended goals, that is to say, does it supply the required functionality with sufficient accuracy?
To be able to do validation tests now, you ought to know of two basics of software testing:
Full testing is not possible.
Testing is always influenced by 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 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 manufactured, often depends on the next point ? the operating environment of the program. Depending on the application, practically, you can find always different requirements and priorities of software use. Additionally, there are customer-specific adjustments to the program, such as concerning 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 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 test for all the needs of a specific customer.
Correspondingly, considering the above points, the validation falls onto the user themself. In order to make this technique as efficient as you possibly can, a procedure fitting the following five points is recommended:
The data for typical calibration configurations ought to be defined as ? Honest ?.
At regular intervals, typically one per year, but at the very least after any software update, these test sets ought to be entered into the software.
The resulting certificates could be weighed against those from the previous version.
Regarding an initial validation, a cross-check, e.g. via MS Excel, can take place.
The validation evidence should be documented and archived.
WIKA offers a PDF documentation of the calculations carried out in the software.
Note
For more info on our calibration software and calibration laboratories, go to the WIKA website.g