ByDesign and FDA/DEA and the Pharmaceutical Industry

[Former Member]

I'm working with a client who needs to have ByDesign "certified" by FDA/DEA. Does anyone know is BYD is certified and/or have come across this requirement before?

[former_member417507]

Hello, any update in this matter?, maybe is Bydesign allready certified in Pharmaceutical?.

Kindle regards,

[jrme_burgaud]

Hello,
I am looking in the community space for the same subject :

U.S. FDA Title 21 CFR Part 11 Compliance Assessments of SAP Business ByDesign

The company will have to qualify to be "FDA Compliant".

The problem is every quarter there is an upgrade that implies the company to re-certify re-qualify the whole IT system. Any feedback on that ?

Best regards
Jérôme BURGAUD

[Former Member]

I'm not 100% sure, but I'm 99.9% sure that it's not. Why would they need this certification?

[Former Member]

I believe this is a requirement within the pharmaceutical industry, something along the lines of an ISO 9000 certification. As I understand, it is a fairly costly endavour.