Validation of calibration software ? as required by ISO 17025, for example ? is No Strings Attached that people don?t prefer to talk about. Almost always there is uncertainty concerning the following: Which software actually should be validated? If so, who should take care of it? Which requirements must be satisfied by validation? How would you do it efficiently and how could it be 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, around fully automated calibration. Whatever the amount of automation of the program, validation always identifies the complete processes into that your program is integrated. Behind validation, therefore, is the fundamental question of whether the process of 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?
In order to do validation tests now, you should be aware 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 a program cannot be performed because of the large number of possible combinations. Based on the application, the user should always decide which functionality, which configurations and quality features should be prioritised and which are not relevant for him.
Which decision is made, often depends on the second point ? the operating environment of the software. According 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 regarding 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 selection 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 check for all the needs of a particular customer.
Correspondingly, considering the above points, the validation falls onto the user themself. In order to make this technique as efficient as possible, a procedure fitting the following five points is recommended:
The info for typical calibration configurations should be thought as ?test sets?.
At regular intervals, typically once a year, but at least after any software update, these test sets ought to be entered into the software.
The resulting certificates could be weighed against 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.