Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that folks don?t prefer to talk about. Often there is uncertainty concerning the following: Which software actually should be validated? If that’s the case, who should look after it? Which requirements should be satisfied by validation? How can เกจวัดแรงดัน do it 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 can be used, among other activities, from supporting the evaluation process, up to fully automated calibration. Whatever the degree of automation of the program, validation always refers to the entire processes into which the program is integrated. Behind validation, therefore, may be the fundamental question of whether the process of 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?
In order to do validation tests now, you should be aware of two basic principles 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 an application cannot be performed because of the large numbers of possible combinations. Depending on application, the user should always decide which functionality, which configurations and quality features must be prioritised and which are not relevant for him.
Which decision is made, often depends on the next point ? the operating environment of the program. With regards to the application, practically, you can find 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 additionally 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 software configurations within the customer-specific application areas therefore make it 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. To make this technique 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 one per year, but at the very least after any software update, these test sets ought to be entered into the software.
The resulting certificates can be weighed against those from the prior version.
Regarding เพรสเชอร์เกิจ , a cross-check, e.g. via MS Excel, may 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 further information on our calibration software and calibration laboratories, go to the WIKA website.