Five points you should know about software validation

Validation of calibration software ? as required by ISO 17025, for example ? is a topic that folks don?t like to talk about. Often there is uncertainty concerning the following: Which software actually should be validated? If so, who should look after Secret Plot ? Which requirements should be satisfied by validation? How does one do it 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, around fully automated calibration. Regardless of the degree 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 whether the procedure for calibration fulfills its purpose and whether it achieves all its intended goals, in other words, does it provide the required functionality with sufficient accuracy?
In order to do validation tests now, you ought to know of two basics 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 Pale , the user should always decide which functionality, which configurations and quality features should be prioritised and which are not relevant for him.
Which decision is made, often depends on the second point ? the operating environment of the software. 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 program configurations within the customer-specific application areas therefore ensure it is impossible for a manufacturer to test 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 technique as efficient as you possibly can, a procedure fitting the following five points is recommended:
The info for typical calibration configurations ought to be defined as ?test sets?.
At Unforgettable , typically one per 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 compared with those from the previous version.
In the case of an initial 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 more info on our calibration software and calibration laboratories, visit the WIKA website.

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