Validation of calibration software ? as required by Argumentative , for instance ? is a topic that folks don?t like to talk about. Often there is uncertainty about 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 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, around fully automated calibration. Regardless of the degree of automation of the software, validation always identifies the entire processes into that your program is integrated. Behind validation, therefore, is the fundamental question of whether 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?
To be able to do validation tests now, you ought to know of two basic principles of software testing:
Full testing is not possible.
Testing is always influenced by the environment.
The former states that the test of all possible inputs and configurations of an application cannot be performed as a result of large number of possible combinations. With regards 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. Depending on the application, practically, there are 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 individual 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 program 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. In order 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 the very least after any software update, these test sets should be entered into the software.
The resulting certificates could be compared with those from the prior version.
Regarding 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 completed in the software.
Note
For more info on our calibration software and calibration laboratories, go to the WIKA website.