Five points you have to know about software validation

ไดอะแฟรม ซีล of calibration software ? as required by ISO 17025, for instance ? is a topic that folks don?t like to talk about. Often there is uncertainty about the following: Which software actually must be validated? If that’s the case, who should take care of it? Which requirements must be satisfied by validation? How does pressure gauge octa take action efficiently and how could it be documented? The following blog 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, around fully automated calibration. Whatever the amount 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 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?
In order 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 most possible inputs and configurations of a program cannot be performed as a result of 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 second point ? ไดอะแฟรม ซีล operating environment of the software. Depending on application, practically, you can find always different requirements and priorities of software use. Additionally, there are customer-specific adjustments to the software, such as regarding 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 make it impossible for a manufacturer to check for all the needs of a specific customer.
Correspondingly, taking into account the above points, the validation falls onto the user themself. In order to make this technique as efficient as possible, a procedure fitting the next five points is recommended:
The data for typical calibration configurations should be defined as ?test sets?.
At regular intervals, typically once a year, but at least after any software update, these test sets should be entered in to the software.
The resulting certificates could be compared with those from the previous version.
Regarding a first 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 completed in the software.
Note
For more info on our calibration software and calibration laboratories, go to the WIKA website.

Scroll to Top