Five points you need to know about software validation

Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that people don? pressure gauge octa prefer to talk about. Often there is uncertainty about the following: Which software actually should be validated? If so, who should take ไดอะแฟรม ซีล of it? Which requirements must be satisfied by validation? How would you take action efficiently and how could it be documented? The following post explains the background and gives a recommendation for implementation in five steps.
In a calibration laboratory, software can be used, among other things, from supporting the evaluation process, up to fully automated calibration. Regardless of the amount of automation of the software, validation always identifies the entire processes into that your program is integrated. Behind validation, therefore, is 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 provide the required functionality with sufficient accuracy?
If you want 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 an application cannot be performed as a result of large numbers of possible combinations. Based on the application, the user must always decide which functionality, which configurations and quality features must be prioritised and which are not relevant for him.
Which ไดอะแฟรม ซีล is made, often depends on the second point ? the operating environment of the program. According to the application, practically, there are 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 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 make it impossible for a manufacturer to check for all the needs of a particular 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 next five points is preferred:
The data for typical calibration configurations ought to be thought 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 into 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, may take place.
The validation evidence ought to be documented and archived.
WIKA provides 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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