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 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 will you do it efficiently and how is it documented? The following blog post explains the background and provides 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 the degree of automation of the software, validation always identifies the complete processes into that your program is integrated. Behind validation, therefore, is the fundamental question of if 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?
If you want to do validation tests now, you should be aware of two basic principles of software testing:
Full testing isn’t possible.
pressure gauge is always dependent on the environment.
The former states that the test of all possible inputs and configurations of an application cannot be performed due to the large numbers of possible combinations. With regards to the application, the user must always decide which functionality, which configurations and quality features must be prioritised and which are not relevant for him.
Which decision is made, often depends on the next point ? the operating environment of the program. According 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 concerning the contents of the certificate. But also the individual conditions in the laboratory environment, with an array of instruments, generate variance. The wide selection of requirement perspectives and the sheer, endless complexity of the program configurations within the customer-specific application areas therefore ensure it is impossible for a manufacturer to test for all the needs of a specific customer.
Correspondingly, taking into account the aforementioned points, the validation falls onto an individual themself. In order to make this process as efficient as possible, a procedure fitting the next 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 ought to be entered in to 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, can take place.
The validation evidence should be documented and archived.
WIKA provides a PDF documentation of the calculations carried out in the software.
For digital pressure gauge on our calibration software and calibration laboratories, go to the WIKA website.