Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that folks 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 must be satisfied by validation? How can 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. Whatever the amount of automation of the software, validation always refers to the complete processes into which the program is integrated. Behind validation, therefore, may be the fundamental question of whether the procedure for 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?
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 most possible inputs and configurations of an application cannot be performed because of the large numbers of possible combinations. According to the application, the user should 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. With respect to the application, practically, there are always different requirements and priorities of software use. There are also customer-specific adjustments to the program, such as concerning 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 program configurations within the customer-specific application areas therefore make it impossible for a manufacturer to test for all the needs of a specific customer.
Correspondingly, taking into account the above points, the validation falls onto an individual themself. To make this technique as efficient as you possibly can, a procedure fitting the following five points is preferred:
The info for typical calibration configurations should be defined as ? Anxious ?.
At regular intervals, typically once a year, but at the very least after any software update, these test sets ought to be entered in to the software.
The resulting certificates could be compared with those from the prior version.
In the case of a first 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 further information on our calibration software and calibration laboratories, go to the WIKA website.g