Five points you need to understand about software validation

Validation of calibration software ? as required by ISO 17025, for example ? 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 that’s the case, who should take care of it? Which requirements must be satisfied by validation? How does one do it efficiently and how could it be documented? เกจวัดแรงดัน following post explains the background and gives 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 degree of automation of the software, validation always refers to 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 supply 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 influenced by the environment.
The former states that the test of all possible inputs and configurations of a program cannot be performed due to the large number 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 made, often depends on the second point ? the operating environment of the program. Depending on pressure gauge octa , practically, there are always different requirements and priorities of software use. There are also customer-specific adjustments to the software, such as concerning the contents of the certificate. But also the average person conditions in the laboratory environment, with an array of instruments, generate variance. The wide selection 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 your needs of a specific customer.
Correspondingly, considering the aforementioned points, the validation falls onto an individual themself. To make this process as efficient as possible, a procedure fitting the following 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 should be entered into the software.
The resulting certificates can be weighed against those from the prior version.
Regarding 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 further information on our calibration software and calibration laboratories, go to the WIKA website.

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