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 like to talk about. Almost always there is uncertainty about the following: Which software actually must be validated? If so, who should look after it? Which requirements must be satisfied by validation? How can 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 is used, among other activities, from supporting the evaluation process, around fully automated calibration. Whatever the amount of automation of the program, 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, that is to say, does it provide 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 is not possible.
Testing is always dependent on the environment.
The former states that the test of all possible inputs and configurations of an application cannot be performed due to large numbers of possible combinations. According to the application, the user must always decide which functionality, which configurations and quality features should be prioritised and that are not relevant for him.
Which decision is manufactured, often depends on the second point ? the operating environment of the program. With respect to the application, practically, you can find always different requirements and priorities of software use. Additionally, there are 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 variety of requirement perspectives and the sheer, endless complexity of the software 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 aforementioned points, the validation falls onto an individual themself. In order to make this process as efficient as you possibly can, a procedure fitting the next five points is preferred:
The info for typical calibration configurations ought to be defined 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 could 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 should be documented and archived.
WIKA offers a PDF documentation of the calculations completed in the software.
Note
For Armageddon on our calibration software and calibration laboratories, visit the WIKA website.

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