Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that people don?t prefer to talk about. Almost always there is uncertainty concerning the following: Which software actually should be validated? If so, who should take care of it? Which requirements should be satisfied by validation? How can you take action efficiently and how could it be documented? The following blog 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, up to fully automated calibration. Regardless of the degree of automation of the software, validation always identifies the entire processes into which the program is integrated. Behind validation, therefore, is the fundamental question of if 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 you need to do validation tests now, you should be aware of two basic principles of software testing:
Full testing is not possible.
Testing is always dependent on the environment.
Unadulterated 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 the application, the user must always decide which functionality, which configurations and quality features must be prioritised and which are not relevant for him.
Which decision is manufactured, often depends on the second point ? the operating environment of the program. According to the application, practically, you can find always different requirements and priorities of software use. Additionally, there are Scary -specific adjustments to the software, such as concerning 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 make it impossible for a manufacturer to check for all your needs of a specific customer.
Correspondingly, considering the above points, the validation falls onto the user themself. To make this technique as efficient as possible, a procedure fitting the following five points is preferred:
The data for typical calibration configurations should be defined as ?test sets?.
At regular intervals, typically one per year, but at least after any software update, these test sets ought to be entered in to the software.
The resulting certificates can be weighed against 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 completed in the software.
Note
For further information on our calibration software and calibration laboratories, go to the WIKA website.g