Validation of calibration software ? as required by ISO 17025, for example ? is a topic that people don?t prefer to talk about. Almost always there is uncertainty concerning the following: Which software actually must be validated? If that’s the case, who should take care of 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 things, from supporting the evaluation process, around fully automated calibration. Regardless of เกจวัดแรงดันnuovafima 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 provide the required functionality with sufficient accuracy?
If you need to do validation tests now, you ought to know 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 most possible inputs and configurations of an application cannot be performed due to the large number of possible combinations. According to 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 decision is made, often depends on the next point ? the operating environment of the software. According to the application, practically, you can find always different requirements and priorities of software use. Additionally, there are customer-specific adjustments to the software, 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 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 process as efficient as you possibly can, a procedure fitting the following five points is preferred:
The info for typical calibration configurations should be defined as ?test sets?.
At regular intervals, typically one per year, but at least after any software update, these test sets ought to be entered into the software.
The resulting certificates can be weighed against those from the previous version.
In the case of an initial 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 carried out in the software.
Note
For further information on our calibration software and calibration laboratories, go to the WIKA website.