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Validating my own application developed with Agile

#1
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:

yodon

Staff member
Super Moderator
#2
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
#3
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.
 
#4
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
#5
Perhaps 21 CFR 211.68 is applicable, since your app will be used in the manufacturing process of drugs.
 
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