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1. Can we customize Odoo 11 Enterprise Edition to make it FDA Compliant for our business flow?
2. Odoo itself has to come forward and get the FDA Compliant certification?
3. Customize Odoo community edition and submit as an entirely new Software to get the certification?

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Odoo is a industry-neutral business software and as such it neither FDA compliant nor FDA non-compliant. As long as Odoo is not providing a vertical solution covered by FDA regulations, there is also no need for it.

As you have the code available of the enterprise version as an enterprise customer, and anyway of the community version, you are technically able and legally allowed to create an FDA compliant vertical yourself or initiate a vertical project on the OCA (Odoo Community Association) platform in order to bundle efforts.

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