Five points you need to understand about software validation

Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that people don?t prefer to talk about. Often there is uncertainty about 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 will you take action 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, up to fully automated calibration. Regardless of the degree of automation of the program, validation always identifies 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 provide the required functionality with sufficient accuracy?
If Unseen need to do validation tests now, you ought to know of two basics of software testing:
Full testing is not 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 the 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 which are not relevant for him.
Which decision is made, often depends on the next point ? the operating environment of the program. With regards to the application, practically, there are always different requirements and priorities of software use. Additionally, there are customer-specific adjustments to the program, such as regarding the contents of the certificate. But also 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 specific customer.
Correspondingly, taking into account the above points, the validation falls onto the user themself. In order to make this technique as efficient as you possibly can, a procedure fitting the following five points is preferred:
The info for typical calibration configurations should be defined as ?test sets?.
At regular intervals, typically one per year, but at the very least after any software update, these test sets ought to be entered in to the software.
The resulting certificates could be weighed against those from the previous version.
In the case of a first validation, a cross-check, e.g. via MS Excel, may take place.
The validation evidence ought to be documented and archived.
WIKA provides a PDF documentation of the calculations carried out in the software.
Note
For more info on our calibration software and calibration laboratories, visit the WIKA website.

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