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 look after it? Which requirements must be satisfied by validation? How can you take action efficiently and how is it documented? The following post explains the background and provides 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 software, validation always refers to the complete processes into that your program is integrated. Behind validation, 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?
If you need to do validation tests now, you ought to know 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 most possible inputs and configurations of a program cannot be performed due to large number of possible combinations. With respect to the application, the user must always decide which functionality, which configurations and quality features must be prioritised and which are not relevant for him.
Which decision is manufactured, 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 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 variety 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 test 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 preferred:
The info for typical calibration configurations ought to be thought as ?test sets?.
At regular intervals, typically once a year, but at the very least after any software update, these test sets ought to be entered into the software.
The resulting certificates can be compared with those from the previous version.
In the case of an initial validation, a cross-check, e.g. via MS Excel, can take place.
The validation evidence ought to be documented and archived.
Enchant provides a PDF documentation of the calculations completed in the software.
Note
For further information on our calibration software and calibration laboratories, visit the WIKA website.