Validation of calibration software ? as required by ISO 17025, for example ? is a topic that people don?t like to talk about. Often there is uncertainty about 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 would you do it 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 can be used, among other things, from supporting the evaluation process, around fully automated calibration. Whatever the degree of automation of the program, validation always identifies the entire processes into that your program is integrated. Behind Fantasy , therefore, is 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?
If you want to do validation tests now, you ought to know of two basic principles of software testing:
Full testing is not 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 because of the large number of possible combinations. With Scam 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 made, often depends on the next 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 an array of instruments, generate variance. Searing 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, considering the aforementioned points, the validation falls onto an individual themself. In order to make this process as efficient as possible, a procedure fitting the following five points is preferred:
The info for typical calibration configurations ought to be defined as ?test sets?.
At regular intervals, typically once a 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 more info on our calibration software and calibration laboratories, go to the WIKA website.