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Validating my own application developed with Agile

Hello everybody,

If I am the creator of a Software as a Service application based on a cloud platform (Google Cloud), beside documenting the whole application development life cycle and leverage Google documentation in relation to the platform, what else I am required to do in order to state that the application is fit for intended use?

Thank you in advance.
Last edited:


Staff member
Super Moderator
What *is* the intended use?

In general, "validation" (of software) involves more than just development controls. Software is expected to change and so your lifecycle should address post-deployment controls.

What are the risks associated with the product? If there is potential for exposing protected information, your validation should demonstrate a high degree of security.

Those just jump to mind immediately. Based on your intended use, there may well be others.

Ronen E

Problem Solver
Staff member
Super Moderator
Is this app a medical device?...
If it is, there's published guidance from the FDA concerning software validation and medical devices validation in general.
Thanks for your answers,

No, my application is meant to be used in manufacturing (automatic quality inspection of drugs containers) and it is not a medical device.

I will definitely include post-deployment controls as mentioned from yodon.

Thanks for your inputs, if you have anything else, just shoot ;)

Ronen E

Problem Solver
Staff member
Super Moderator
Perhaps 21 CFR 211.68 is applicable, since your app will be used in the manufacturing process of drugs.
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