Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that people don?t like to talk about. Almost always there is uncertainty concerning 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 do 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, around fully automated calibration. Whatever the amount of automation of the software, validation always refers to the entire processes into which the program is integrated. Behind validation, therefore, is the fundamental question of whether the procedure for calibration fulfills its purpose and whether it achieves all its intended goals, in other words, does it provide 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.
Trapped is always dependent on the environment.
The former states that the test of most possible inputs and configurations of a program cannot be performed because of the large numbers of possible combinations. With respect to the application, the user should 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 software. Depending on the 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 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 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, considering the above points, the validation falls onto an individual themself. In order to make this process as efficient as possible, a procedure fitting the next five points is preferred:
The info for typical calibration configurations ought to be thought 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 in to 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, may take place.
The validation evidence ought to 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.