Validation of calibration software ? as required by ISO 17025, for example ? is a topic that folks don?t prefer to talk about. Often there is uncertainty concerning the following: Which software actually should be validated? If that’s the case, who should look after it? Which requirements must be satisfied by validation? How would you take action efficiently and how is it documented? The following post explains the background and gives a recommendation for implementation in five steps.
In Simple , software can be used, among other activities, from supporting the evaluation process, up to fully automated calibration. Whatever Sensual of automation of the program, validation always refers to the complete 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, in other words, does it supply the required functionality with sufficient accuracy?
In Sexy to do validation tests now, you ought to know of two basics of software testing:
Full testing is not 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 due to the large numbers of possible combinations. Depending on 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 decision is manufactured, often depends on the second point ? the operating environment of the program. 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 concerning the contents of the certificate. But additionally the average person conditions in the laboratory environment, with an array 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 make it impossible for a manufacturer to test for all the needs of a particular customer.
Correspondingly, considering the above points, the validation falls onto an individual themself. To make this technique as efficient as possible, a procedure fitting the next five points is preferred:
The info for typical calibration configurations ought to be defined as ?test sets?.
At regular intervals, typically one per year, but at least after any software update, these test sets should be entered in to the software.
The resulting certificates can be weighed against those from the prior version.
In the case of an initial 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 carried out in the software.
Note
For further information on our calibration software and calibration laboratories, visit the WIKA website.