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 about the following: Which software actually must be validated? If that’s the case, who should look after it? Which ไดอะแฟรม ซีล should be satisfied by validation? How can you take action 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 things, from supporting the evaluation process, around fully automated calibration. Whatever diaphragm seal of automation of the program, validation always refers to 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 supply the required functionality with sufficient accuracy?
In order to do validation tests now, you should be aware of two basics of software testing:
Full testing isn’t possible.
เกจวัดแรงดัน is always influenced by the environment.
The former states that the test of most possible inputs and configurations of a program cannot be performed as a result of large number of possible combinations. With regards to the 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. Additionally, there are customer-specific adjustments to the program, 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 make it impossible for a manufacturer to test for all the needs of a specific 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 regular intervals, typically once a year, but at the very least after any software update, these test sets ought to be entered into the software.
The resulting certificates could be compared with those from the prior version.
Regarding a first validation, a cross-check, e.g. via MS Excel, can 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.