Validation of calibration software ? as required by ISO 17025, for example ? is a topic that folks don?t like to talk about. Almost always there is uncertainty concerning 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 does one do it efficiently and how is it documented? The following post explains the background and gives a recommendation for implementation in five steps.
In a calibration laboratory, software can be used, among other things, from supporting the evaluation process, up to fully automated calibration. Regardless of the degree of automation of the program, validation always identifies the complete processes into that your 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, in other words, 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 influenced by the environment.
The former states that the test of most possible inputs and configurations of a program cannot be performed as a result of large numbers of possible combinations. According to the application, the user should 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 next point ? the operating environment of the program. Depending on A Cut Above , practically, you can find 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 ensure it is impossible for a manufacturer to check for all the needs of a specific customer.
Correspondingly, taking into account the aforementioned points, the validation falls onto an individual themself. 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 ?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.
In the case of an initial validation, a cross-check, e.g. via MS Excel, may take place.
The validation evidence ought to 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.