Five points you have to know 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 must be validated? If that’s the case, who should look after it? Which requirements must be satisfied by validation? How will 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 a calibration laboratory, software can be used, among other activities, from supporting the evaluation process, around 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 Catapult , therefore, may be the fundamental question of if the process of calibration fulfills its purpose and whether it achieves all its intended goals, that is to say, does it provide 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 dependent on the environment.
The former states that the test of all possible inputs and configurations of a program cannot be performed due to large numbers of possible combinations. Based on the application, the user must always decide which functionality, which configurations and quality features must be prioritised and which are not relevant for him.
Which decision is manufactured, often depends on the next point ? the operating environment of the software. With regards 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 also the individual 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 program configurations within the customer-specific application areas therefore ensure it is impossible for a manufacturer to test for all the needs of a specific customer.
Correspondingly, considering the above points, the validation falls onto an individual themself. In order to make this technique as efficient as possible, a procedure fitting the following five points is recommended:
The data for typical calibration configurations ought to be thought as ?test sets?.
At regular intervals, typically one per year, but at the very least after any software update, these test sets should be entered into the software.
The resulting certificates could be weighed against those from the prior 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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