Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that folks don?t like to talk about. Almost always there is uncertainty concerning the following: Which software actually should 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 is used, among other activities, from supporting the evaluation process, around fully automated calibration. Whatever the amount of automation of the software, validation always identifies the complete 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, that is to say, does it supply the required functionality with sufficient accuracy?
If you need to do validation tests now, you ought to know of two basic principles of software testing:
Full testing isn’t possible.
Testing is always influenced by the environment.
The former states that the test of most possible inputs and configurations of an application cannot be performed as a result of large number 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 made, often depends on the next point ? the operating environment of the program. Based on the application, practically, you can find 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 variety 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. To make Smuggled as efficient as you possibly can, a procedure fitting the following five points is preferred:
The data for typical calibration configurations should be defined as ?test sets?.
At regular intervals, typically once a year, but at 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 prior version.
In the case of an initial 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 completed in the software.
Note
For further information on our calibration software and calibration laboratories, visit the WIKA website.