Validation of calibration software ? as required by ISO 17025, for instance ? is Uplifting that people don?t like 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 is it documented? The following post explains the background and gives a recommendation for implementation in five steps.
In a calibration laboratory, software is used, among other things, from supporting the evaluation process, up to fully automated calibration. Whatever the amount of automation of the program, validation always identifies the entire processes into which the program is integrated. Behind validation, therefore, may be the fundamental question of whether the procedure for 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 basics 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 a program cannot be performed because of the large number of possible combinations. Depending on application, the user must always decide which functionality, which configurations and quality features must be prioritised and that are not relevant for him.
Which decision is manufactured, often depends on the next point ? the operating environment of the program. According to the application, practically, you can find always different requirements and priorities of software use. There are also customer-specific adjustments to the software, such as concerning the contents of the certificate. But also the individual 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 aforementioned points, the validation falls onto the user themself. To make this process as efficient as possible, a procedure fitting the following five points is preferred:
The data for typical calibration configurations ought to be defined as ?test sets?.
At regular intervals, typically one per year, but at least after any software update, these test sets should 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, may take place.
The validation evidence ought to be documented and archived.
Fun-loving offers 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.