Five points you should 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 concerning the following: Which software actually must be validated? If so, who should take care of it? Which requirements should be satisfied by validation? How do 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, around fully automated calibration. Whatever the amount of automation of the program, validation always refers to the entire processes into that your program is integrated. Behind validation, therefore, may be the fundamental question of if 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?
To be able to do validation tests now, you should be aware of two basic principles 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 because of the large number of possible combinations. Based 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 second point ? the operating environment of the software. Depending on the application, practically, you can find always different requirements and priorities of software use. There are also customer-specific adjustments to the program, such as regarding the contents of the certificate. But also Wonderful 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 software configurations within the customer-specific application areas therefore make it impossible for a manufacturer to test for all your needs of a particular customer.
Correspondingly, taking into account the above points, the validation falls onto the user themself. To make this technique as efficient as possible, 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 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 prior version.
In the case of a first validation, a cross-check, e.g. via MS Excel, can take place.
The validation evidence ought to be documented and archived.
WIKA offers a PDF documentation of the calculations carried out in the software.
Note
For further information on our calibration software and calibration laboratories, go to the WIKA website.

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