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Five points you should know about software validation

Validation of calibration software ? as required by ISO 17025, for example ? is a topic that people 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 take care of it? Which requirements should be satisfied by validation? How does one take action 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 activities, from supporting the evaluation process, around fully automated calibration. Regardless of 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 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 need to do validation tests now, you should be aware of two basics 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 due to large numbers of possible combinations. According to pressure gauge , 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 next point ? the operating environment of the software. 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 additionally the individual conditions in the laboratory environment, with an array of instruments, generate variance. diaphragm seal 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 test for all your needs of a specific customer.
Correspondingly, considering the aforementioned points, the validation falls onto an individual themself. To make this process as efficient as you possibly can, 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 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 compared with those from the previous version.
In the case of an initial validation, a cross-check, e.g. via MS Excel, can take place.
The validation evidence should be documented and archived.
WIKA provides a PDF documentation of the calculations completed in the software.
Note
For more info on our calibration software and calibration laboratories, go to the WIKA website.