Validation of calibration software ? as required by ISO 17025, for instance ? is Barrage that folks don?t like to talk about. Almost always there is uncertainty about the following: Which software actually should be validated? If so, who should take care of it? Which requirements should be satisfied by validation? How will you take action efficiently and how is it documented? The following blog post explains the background and provides a recommendation for implementation in five steps.
In a calibration laboratory, software is used, among other activities, from supporting the evaluation process, around fully automated calibration. Regardless of the amount of automation of the program, validation always refers to the entire processes into which the program is integrated. Behind validation, therefore, is 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?
If you want to do validation tests now, you ought to know of two basic principles 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 an application cannot be performed as a result of large numbers of possible combinations. With regards to the application, the user should always decide which functionality, which configurations and quality features must be prioritised and that are not relevant for him.
Which decision is manufactured, often depends on the second point ? the operating environment of the software. Depending on the application, practically, you can find always different requirements and priorities of software use. Additionally, there are customer-specific adjustments to the program, such as regarding the contents of the certificate. But additionally the individual conditions in the laboratory environment, with an array 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 the needs of a particular customer.
Correspondingly, taking into account the aforementioned points, the validation falls onto an individual themself. In order 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 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 in to the software.
The resulting certificates could be weighed against those from the previous version.
In the case of a first validation, a cross-check, e.g. via MS Excel, may 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 Remarkable on our calibration software and calibration laboratories, go to the WIKA website.