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 must be satisfied by validation? How do you 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 can be used, among other activities, from supporting the evaluation process, around fully automated calibration. Regardless of the amount of automation of the software, validation always refers to the entire processes into which the program is integrated. Behind validation, therefore, may be the fundamental question of if the procedure for 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 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. With respect to the application, the user must always decide which functionality, which configurations and quality features must be prioritised and that are not relevant for him.
Which Left Behind is manufactured, often depends on the next point ? the operating environment of the software. With regards to the application, practically, there are always different requirements and priorities of software use. Additionally, there are customer-specific adjustments to the software, such as regarding the contents of the certificate. But additionally the individual 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 make it impossible for a manufacturer to check for all your needs of a particular customer.
Correspondingly, taking into account the above points, the validation falls onto the user themself. In order to make this process as efficient as you possibly can, a procedure fitting the next five points is preferred:
The data for typical calibration configurations ought to be thought as ?test sets?.
At regular intervals, typically one per year, but at the very least after any software update, these test sets should be entered into the software.
The resulting certificates could be weighed against those from the previous 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 carried out in the software.
Note
For further information on our calibration software and calibration laboratories, visit the WIKA website.