Five points you have to know about software validation

Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that folks don?t like to talk about. Almost always there is uncertainty about the following: Which software actually must 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 provides a recommendation for implementation in five steps.
In a calibration laboratory, software is used, among other activities, from supporting the evaluation process, up to fully automated calibration. Regardless of the amount of automation of the program, validation always identifies the complete processes into which the program is integrated. Behind validation, therefore, may be 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 supply the required functionality with sufficient accuracy?
If you want to do validation tests now, you ought to know of two basics of software testing:
Full testing is not possible.
Horrific is always influenced by the environment.
The former states that the test of all possible inputs and configurations of an application cannot be performed due to large number of possible combinations. With regards 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 made, often depends on the second point ? the operating environment of the software. With respect to the application, practically, there are always different requirements and priorities of software use. Additionally, there are customer-specific adjustments to the software, such as concerning the contents of the certificate. But additionally the individual 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 test for all your needs of a particular customer.
Correspondingly, considering the aforementioned points, the validation falls onto an individual themself. In order to make this process as efficient as you possibly can, a procedure fitting the next five points is recommended:
The data for typical calibration configurations ought to be defined 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 into the software.
The resulting certificates could be weighed against those from the previous version.
Regarding an initial 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 more info on our calibration software and calibration laboratories, visit the WIKA website.

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