Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that people don?t prefer to talk about. Often there is uncertainty concerning the following: Which software actually must be validated? If that’s the case, who should look after it? Which requirements should be satisfied by validation? How do you do it efficiently and how is it documented? The following blog post explains the background and provides a recommendation for implementation in five steps.
In a calibration laboratory, software is used, among other things, from supporting the evaluation process, around fully automated calibration. Regardless of the degree of automation of the software, validation always refers to the entire processes into that your program is integrated. Behind validation, 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?
If Tested need 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 a program cannot be performed as a result of large number of possible combinations. According 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 Serene -specific adjustments to the software, such as concerning the contents of the certificate. But additionally the average person conditions in the laboratory environment, with a wide range 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 ensure it is impossible for a manufacturer to test for all your needs of a particular customer.
Correspondingly, considering 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 data for typical calibration configurations should be defined as ?test sets?.
At regular intervals, typically one per year, but at the very least after any software update, these test sets should be entered into the software.
The resulting certificates can be compared with those from the previous version.
Regarding a first validation, a cross-check, e.g. via MS Excel, may take place.
The validation evidence should be documented and archived.
Unlimited provides 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.