Hello Martin.Bean.Tangerine.Software, 

Thanks for reaching out! I followed up with the strategic account manager team who may have already forwarded you this document white paper with the certification details. Yes Sage Enterprise Management is certified.
EnterpriseManagement_CFR21_Compliance.pdf

Warm Regards,
Erzsi

FWIW no one "Certifies" software as compliant.  There is no FDA certification process, like ISO certification.   Is Sage X3/EM compliant?   It can be used in a compliant manner and has the necessary features to be used in this manner and has been used by many people successfully in this role.

It is kind of like GAAP or DCAA "certification".   There is no agency to certify that your software is GAAP or GAAS or DCAA compliant.  There is no common body of knowledge that says what those requirements would be in a software package.  An auditor might look at the operation of the software and determine that it has the necessary tools to be used in a compliant manner or that it is auditable.  

It's the CPA in me that makes me talk like this.  I apologize.  I am considering rehab. 

I agree, it's important to understand the product is not FDA certify but the company meaning the entire organization. A simple example, if the users are not trained enough or if there are no internal procedures then event the most controled software cannot prevent an error. On the opposite, if a control is missing, then maybe a manual procedure (tracked on paper) can be enough to be compliant. 

From experience, if a customer requests such certification, it increases the implementation load: you will need to deliver a very detailed documentation along the project (higher than the usual) and most likely the certifying company will request some time / information (or even training) from the integrator team.