Five points you have to know about software validation

Validation of calibration software ? as required by Harsh , for example ? is a topic that folks don?t prefer to talk about. Almost always there is uncertainty concerning the following: Which software actually must be validated? If so, who should take care of it? Which requirements must be satisfied by validation? How does one take action efficiently and how could it be documented? The following blog post explains the background and provides a recommendation for implementation in five steps.
In Heavenly , software can be used, among other activities, from supporting the evaluation process, up to fully automated calibration. Regardless of the degree of automation of the software, validation always identifies the entire processes into which the program is integrated. Behind validation, therefore, may be the fundamental question of if the procedure for calibration fulfills its purpose and whether it achieves all its intended goals, in other words, does it provide the required functionality with sufficient accuracy?
To be Backstabbing to do validation tests now, you should be aware of two basics 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 as a result of large number of possible combinations. Depending on the application, the user must always decide which functionality, which configurations and quality features should 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 regards to the application, practically, you can find 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 average person 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 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 above points, the validation falls onto an individual themself. In order to make this technique as efficient as possible, a procedure fitting the next five points is recommended:
The info for typical calibration configurations should be defined 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 into 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 should be documented and archived.
WIKA offers a PDF documentation of the calculations carried out in the software.
Note
For more info on our calibration software and calibration laboratories, go to the WIKA website.

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