Validation of calibration software ? as required by ISO 17025, for example ? is a topic that people don?t like to talk about. Almost always there is uncertainty about the following: Which software actually should be validated? If so, who should look after it? Which requirements must be satisfied by validation? How would you do it efficiently and how could it be documented? diaphragm seal following blog post explains the background and provides a recommendation for implementation in five steps.
In ไดอะแฟรม ซีล , software is used, among other activities, from supporting the evaluation process, around fully automated calibration. Whatever the degree of automation of the program, validation always refers to 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, in other words, does it supply the required functionality with sufficient accuracy?
If you want to do validation tests now, you ought to know 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 an application cannot be performed because of the large numbers of possible combinations. Depending on 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 made, often depends on the second point ? the operating environment of the program. Depending on the application, practically, there are always different requirements and priorities of software use. There are also customer-specific adjustments to the program, such as concerning the contents of the certificate. But additionally the individual conditions in the laboratory environment, with an array 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. In order to make this technique as efficient as you possibly can, a procedure fitting the following five points is recommended:
The data for typical calibration configurations should be thought as ?test sets?.
At regular intervals, typically one per 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 previous version.
In the case of an initial validation, a cross-check, e.g. via MS Excel, can 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, go to the WIKA website.