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 about 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 will you take action 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 activities, from supporting the evaluation process, around fully automated calibration. Regardless of the amount 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, in other words, does it provide the required functionality with sufficient accuracy?
In order 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 all possible inputs and configurations of a program cannot be performed due to the large number of possible combinations. With regards to the application, the user should always decide which functionality, which configurations and quality features should be prioritised and which are not relevant for him.
Which decision is made, often depends on the second point ? the operating environment of the software. With respect 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 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 selection 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 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 recommended:
The info for typical calibration configurations ought to be thought as ?test sets?.
At Naughty , 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 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.
Note
For more info on our calibration software and calibration laboratories, go to the WIKA website.