FDA tracking with S/4 HANA Cloud Public Edition

[Antoine]

Hi team,

do you know how do we ensure that an Public Cloud ERP system (S/4 Hana Cloud Public Edition) can be compliant with FDA or CSA Certifications ?

whether it's for Consumer Products, cosmestics or Healthcare/Medcare, how do we tackle this issue ?

Thanks !

SAP S/4HANA Cloud Public Edition Finance  

[AndreasMuno · Accepted solution]

Hi @Antoine ,

you ask how we tackle the issue of compliance with certifications imposed by FDA, CSA and other such authorities. The quick answer is, we do not. Unless specified, it is not typically software providers' obligation to meet those certification requirements. An 'entity' in regulated industries may however be required to get audited for their processes, practices and IT infrastructure and to ensure they comply with that industry's regulatory requirements. Where processes, etc., may be deemed insufficient, they, the 'entity' may be required to adapt their processes, etc., accordingly. 

SAP provides for adaptability of their software through configuration and extension capabilities. SAP also provides for best practices across many lines of business, industries, and countries. However, it is always the software using entity that has to maintain its compliance with regulations, not the supplier. 

SAP does comply with an array of regulatory requirements across multiple countries. With which exactly and in respect to what products you can find on the Compliance pages of sap.com, here.

If this response was helpful to you, please mark it accordingly. Thank you.             

[Antoine · Accepted solution]

Thanks a million!