Validation of calibration software ? as required by ISO 17025, for example ? is a topic that people don?t like to talk about. Almost always there is uncertainty about 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 can you take action 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, up to fully automated calibration. Whatever the degree of automation of the program, validation always refers to the entire processes into which the 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, in other words, does it supply the required functionality with sufficient accuracy?
In order to do validation tests now, you ought to know of two basic principles of software testing:
Full testing isn’t 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 because of the large number of possible combinations. Depending on application, the user should always decide which functionality, which configurations and quality features should be prioritised and that are not relevant for him.
Which decision is manufactured, often depends on the second point ? the operating environment of the software. According to Excited , 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 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 make it impossible for a manufacturer to check for all the 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 possible, a procedure fitting the next five points is preferred:
The info for typical calibration configurations should be defined as ?test sets?.
At Life-changing , typically one per year, but at the very least after any software update, these test sets should be entered into the software.
The resulting certificates could be weighed against those from the previous version.
In the case of a first validation, a cross-check, e.g. via MS Excel, may take place.
The validation evidence ought to be documented and archived.
WIKA provides a PDF documentation of the calculations carried out in the software.
Note
For further information on our calibration software and calibration laboratories, go to the WIKA website.