Validation of calibration software ? as required by ISO 17025, for example ? is Hoak that people don?t like to talk about. Almost always there is uncertainty concerning the following: Which software actually should be validated? If so, who should look after it? Which requirements should be satisfied by validation? How does one do it efficiently and how could it be documented? The following 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 amount of automation of the software, validation always refers to the entire processes into that your program is integrated. Behind validation, therefore, may be 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 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 as a result of 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 Is Here is manufactured, often depends on the next point ? the operating environment of the software. Based on the application, practically, there are always different requirements and priorities of software use. There are also customer-specific adjustments to the software, such as concerning the contents of the certificate. But also the individual conditions in the laboratory environment, with an array 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 your needs of a particular customer.
Correspondingly, considering the above points, the validation falls onto an individual themself. 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 defined as ?test sets?.
At regular intervals, typically once a year, but at least after any software update, these test sets should be entered in to the software.
The resulting certificates can be compared with those from the prior version.
Regarding a first validation, a cross-check, e.g. via MS Excel, can take place.
The validation evidence ought to be documented and archived.
WIKA offers a PDF documentation of the calculations completed in the software.
Note
For further information on our calibration software and calibration laboratories, go to the WIKA website.