Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that folks don?t prefer to talk about. Almost always there is uncertainty about the following: Which software actually should be validated? If that’s the case, who should look after it? Which requirements must be satisfied by validation? How would digital pressure gauge take action 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 is used, among other things, from supporting the evaluation process, up to fully automated calibration. Regardless of the degree of automation of the software, validation always refers to the complete 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, that is to say, does it provide the required functionality with sufficient accuracy?
If you need 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.
The former states that the test of most possible inputs and configurations of a program cannot be performed as a result of large number of possible combinations. Based on ไดอะแฟรม ซีล , 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 second point ? the operating environment of the software. With regards to 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 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 variety 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 your needs of a particular customer.
Correspondingly, taking into account the aforementioned points, the validation falls onto an individual themself. To make this process as efficient as you possibly can, a procedure fitting the next five points is recommended:
The info for typical calibration configurations should 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 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 provides a PDF documentation of the calculations carried out in the software.
Note
For more info on our calibration software and calibration laboratories, visit the WIKA website.