Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that people don?t like to talk about. digital pressure gauge 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 should 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 is used, among other things, from supporting the evaluation process, around fully automated calibration. Regardless of the amount of automation of the program, validation always refers to the entire processes into that your program is integrated. Behind validation, therefore, may be the fundamental question of whether the process of 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?
If you want to do validation tests now, you should be aware 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 most possible inputs and configurations of a program cannot be performed because of 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 second point ? the operating environment of the program. Depending on application, 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 additionally 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 the needs of a particular customer.
Correspondingly, considering the above points, the validation falls onto an individual themself. In order to make this technique as efficient as possible, a procedure fitting the next five points is preferred:
The info for typical calibration configurations ought to 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 into the software.
The resulting certificates can be weighed against those from the prior version.
Regarding a first validation, a cross-check, e.g. via MS Excel, can take place.
The validation evidence ought to be documented and archived.
WIKA offers a PDF documentation of the calculations completed in the software.
Note
For further information on our calibration software and calibration laboratories, visit the WIKA website.