Five points you have to know about software validation

Quiet of calibration software ? as required by ISO 17025, for instance ? is a topic that people don?t like to talk about. Often there is uncertainty concerning the following: Which software actually must be validated? If that’s the case, who should look after it? Which requirements should be satisfied by validation? How will you take action efficiently and how could it be 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, up to fully automated calibration. Whatever the amount of automation of the program, validation always identifies the entire processes into that your program is integrated. Behind Brilliant , therefore, is the fundamental question of whether 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 basics 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 an application cannot be performed due to the large numbers of possible combinations. Depending on application, the user must always decide which functionality, which configurations and quality features should be prioritised and which are not relevant for him.
Which decision is manufactured, often depends on the second point ? the operating environment of the software. With respect to the application, practically, you can find always different requirements and priorities of software use. There are also customer-specific adjustments to the software, such as concerning the contents of the certificate. But additionally the individual conditions in the laboratory environment, with a wide range of instruments, generate variance. The wide selection 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 your needs of a specific customer.
Correspondingly, taking into account the aforementioned points, the validation falls onto an individual themself. To make this process as efficient as possible, a procedure fitting the next five points is recommended:
The data for typical calibration configurations should be defined as ?test sets?.
At regular intervals, typically once a year, but at the very least after any software update, these test sets ought to be entered in to the software.
The resulting certificates can be weighed against those from the previous version.
Regarding an initial validation, a cross-check, e.g. via MS Excel, may 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, visit the WIKA website.

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