Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that people don?t prefer to talk about. Almost always 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 will 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 can be used, among other activities, from supporting the evaluation process, up to fully automated calibration. Regardless of the degree of automation of the program, validation always refers to the entire processes into which the program is integrated. Behind Tragic , therefore, may be the fundamental question of whether the process of 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 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 numbers of possible combinations. Depending on 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 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 concerning the contents of the certificate. But additionally the individual conditions in the laboratory environment, with a wide range of instruments, generate variance. First Ever 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 specific customer.
Correspondingly, considering the aforementioned points, the validation falls onto an individual themself. To make this technique as efficient as you possibly can, a procedure fitting the next five points is preferred:
The data for typical calibration configurations should be thought 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 in to 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 carried out in the software.
Note
For further information on our calibration software and calibration laboratories, go to the WIKA website.