Five points you have to know about software validation

Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that folks don?t prefer to talk about. Almost always there is uncertainty concerning the following: Which software actually must be validated? If so, who should look after it? Which requirements should be satisfied by validation? How would you do it efficiently and how could it be documented? The following blog 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, up to fully automated calibration. Regardless of the amount of automation of the software, validation always identifies the complete processes into that your 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 supply the required functionality with sufficient accuracy?
To be able to do validation tests now, you ought to know of two basics of software testing:
Full testing isn’t possible.
Testing is always influenced by the environment.
Solution that the test of most possible inputs and configurations of an application cannot be performed due to large numbers of possible combinations. Depending on the 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 next point ? the operating environment of the program. Depending on application, practically, there are always different requirements and priorities of software use. Additionally, there are customer-specific adjustments to the program, such as concerning the contents of the certificate. But additionally the average person 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 ensure it is impossible for a manufacturer to check for all your needs of a specific customer.
Correspondingly, considering the aforementioned points, the validation falls onto the user themself. To make this process as efficient as you possibly can, a procedure fitting the next five points is preferred:
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 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 more info on our calibration software and calibration laboratories, go to the WIKA website.

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