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 concerning the following: Which software actually should be validated? If that’s the case, who should take care of it? Which Sale must be satisfied by validation? How do you do it efficiently and how could it be documented? The following blog post explains the background and gives a recommendation for implementation in five steps.
In a calibration laboratory, software is used, among other activities, from supporting the evaluation process, up to fully automated calibration. Regardless of the amount of automation of the program, validation always identifies 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, that is to say, does it supply the required functionality with sufficient accuracy?
In Heartbreaking to do validation tests now, you ought to know 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 most possible inputs and configurations of a program cannot be performed as a result of large numbers of possible combinations. Depending on application, the user should 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 second point ? the operating environment of the program. Depending on Slave , practically, there are always different requirements and priorities of software use. There are also customer-specific adjustments to the program, such as concerning the contents of the certificate. But also the individual conditions in the laboratory environment, with a wide range of instruments, generate variance. The wide variety of requirement perspectives and the sheer, endless complexity of the software configurations within the customer-specific application areas therefore ensure it is impossible for a manufacturer to check for all your needs of a particular customer.
Correspondingly, considering the above points, the validation falls onto the user themself. To make this technique as efficient as possible, a procedure fitting the next five points is preferred:
The data 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 compared with those from the previous version.
Regarding a first validation, a cross-check, e.g. via MS Excel, may take place.
The validation evidence should be documented and archived.
WIKA offers a PDF documentation of the calculations completed in the software.
Note
For more info on our calibration software and calibration laboratories, visit the WIKA website.