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Five points you need to understand about software validation

Validation of calibration software ? as required by ISO 17025, for example ? is a topic that folks don?t prefer to talk about. Almost always there is uncertainty concerning the following: Which software actually should be validated? If so, who should look after it? Which requirements must be satisfied by validation? How can you do it efficiently and how is it documented? The following post explains the background and gives a recommendation for implementation in five steps.
In เกจวัดแรงดัน , software is 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, may be 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 should be aware 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 most possible inputs and configurations of a program cannot be performed due to large number of possible combinations. With regards to the application, the user must always decide which functionality, which configurations and quality features must be prioritised and that are not relevant for him.
Which decision is made, often depends on the second point ? the operating environment of the software. Depending on application, practically, there are 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 also 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 make it impossible for a manufacturer to check for all the needs of a specific customer.
Correspondingly, taking into account the aforementioned points, the validation falls onto an individual themself. In order to make this process as efficient as possible, a procedure fitting the following five points is preferred:
The info for typical calibration configurations ought to be defined as ?test sets?.
At regular intervals, typically once a 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 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 offers a PDF documentation of the calculations carried out in the software.
Note
For more info on our calibration software and calibration laboratories, go to the WIKA website.