Five points you should know about software validation

Validation of calibration software ? as required by ISO 17025, for instance ? is a topic that people don?t like to talk about. Maul there is uncertainty concerning the following: Which software actually should be validated? If that’s the case, who should take care of it? Which requirements should be satisfied by validation? How does one take action efficiently and how could it be documented? Astounding following blog 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. Regardless of the degree of automation of the software, validation always refers to 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, that is to say, does it provide the required functionality with sufficient accuracy?
In order to do validation tests now, you ought to know of two basic principles of software testing:
Full testing is not possible.
Testing is always dependent on the environment.
The former states that the test of all possible inputs and configurations of a program 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 should 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. Depending on the application, practically, there are always different requirements and priorities of software use. There are also customer-specific adjustments to the software, such as regarding 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 software configurations within the customer-specific application areas therefore ensure it is impossible for a manufacturer to test for all your needs of a specific customer.
Correspondingly, considering the aforementioned points, the validation falls onto an individual themself. To make this process as efficient as you possibly can, a procedure fitting the next five points is preferred:
The data for typical calibration configurations ought to be thought 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 weighed against those from the previous version.
In the case of an initial 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 completed in the software.
Note
For more info on our calibration software and calibration laboratories, visit the WIKA website.

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