Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that people don?t like to talk about. Often there is uncertainty about the following: Which software actually must be validated? If so, who should take care of it? Which requirements must be satisfied by validation? How do you do it efficiently and how could it be 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 activities, from supporting the evaluation process, around fully automated calibration. Whatever ไดอะแฟรม ซีล of automation of the program, validation always refers to 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, in other words, does it provide the required functionality with sufficient accuracy?
If you need to do validation tests now, you ought to know of two basics of software testing:
Full testing is not 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 because of the large number of possible combinations. Depending on 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 program. With regards to the application, practically, there are always different requirements and priorities of software use. There are also 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 selection of requirement perspectives and the sheer, endless complexity of the program configurations within the customer-specific application areas therefore ensure it is impossible for a manufacturer to test for all the needs of a particular customer.
Correspondingly, considering the aforementioned points, the validation falls onto an individual themself. To make this process as efficient as possible, a procedure fitting the following five points is recommended:
The data for typical calibration configurations ought to 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 could be compared with those from the prior version.
In the case of an initial validation, a cross-check, e.g. via MS Excel, may take place.
The validation evidence should be documented and archived.
WIKA provides a PDF documentation of the calculations completed in the software.
Note
For further information on our calibration software and calibration laboratories, visit the WIKA website.