FDA CFR 21 and obsolete ERP

[Former Member]

Good morning all,

One of my customer is currently running  a SAP Entreprise 4.7 release which will not be supported but SAP after march 2013.

One of is plant / factory has to start a FDA CRF 21 certification process in 2013. He does not want to perform an upgrade to ECC6 in 2013.

Is the obsolete unsupported ERP, a show stopper for the FDA certification.

Thanks.

Cédric

[oliver_nuernberg]

Hi Cedric,

why should this be a showstopper? If you have validated your system you shoud be OK. "unsupported" in this context just means that if you find an issue you cannot post a ticket to SAP. But you can still get a consultant to fix the problem. I don't see a reason, why this MUST be done by SAP form an FDA validation prespective.

Oliver