Validation of calibration software ? as required by ISO 17025, for instance ? is pressure gauge ยี่ห้อ tk that folks don?t prefer to talk about. Almost always there is uncertainty about the following: Which software actually should be validated? If that’s the case, 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 blog 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. Regardless of the degree of automation of the software, validation always identifies the entire processes into that your 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, in other words, does it provide the required functionality with sufficient accuracy?
To be able to do validation tests now, you ought to know 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 all possible inputs and configurations of an application cannot be performed as a result of large number of possible combinations. Depending on application, the user should 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 next point ? the operating environment of the software. According to the application, 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 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 make it impossible for a manufacturer to test for all your 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 possible, a procedure fitting the next five points is recommended:
The info for typical calibration configurations should be thought as ?test sets?.
At regular intervals, typically once a year, but at 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.
Regarding a first validation, a cross-check, e.g. via MS Excel, can take place.
The validation evidence should be documented and archived.
WIKA provides a PDF documentation of the calculations carried out in the software.
Note
For further information on our calibration software and calibration laboratories, visit the WIKA website.