Validation of calibration software ? as required by ISO 17025, for example ? is a topic that people don?t like to talk about. Often there is uncertainty concerning the following: Which software actually must be validated? If so, who should take care of it? Which requirements should be satisfied by validation? How can you 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 is used, among other activities, from supporting the evaluation process, up to fully automated calibration. Regardless of the degree of automation of the program, validation always refers to the complete processes into that your program is integrated. Behind ไดอะแฟรม ซีล , therefore, is 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?
To be digital pressure gauge to do validation tests now, you ought to know of two basic principles of software testing:
Full testing is not possible.
Testing is always dependent on the environment.
The former states that the test of most possible inputs and configurations of an application cannot be performed as a result of large number of possible combinations. With respect to the application, 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 next point ? the operating environment of the program. Depending on application, practically, there are always different requirements and priorities of software use. Additionally, there are customer-specific adjustments to the program, such as regarding the contents of the certificate. But also the average person 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 ensure it is impossible for a manufacturer to check for all the needs of a specific customer.
Correspondingly, taking into account the aforementioned points, the validation falls onto the user themself. To make this technique as efficient as possible, a procedure fitting the next five points is recommended:
The info for typical calibration configurations ought to be thought 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 in to the software.
The resulting certificates can be compared with those from the previous version.
In the case of a first 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, go to the WIKA website.