Sage 100

We have been down this path about 15 years ago with regard to Microsoft Dynamics NAV.  I haven't kept up with FDA 21 CFR part 11 regs and validation requirements since then.  But back then, it was going to cost the client over $100K to "validate" unmodified Dynamics NAV initially, and then considerable ongoing costs on top of that.  In addition, like almost all NAV users, they wanted lots of customizations which would then drive up the costs almost exponentially.  At the time, the validation required lots of commitments and special procedures from the software publisher in terms of how they manage their development operations and release software.  Needless to say, this concept was DOA with Microsoft as we were going to have no luck in persuading them change their procedures in order to meet these requirements.

I have come across publishers or ISVs that have developed offerings specifically targeted at organizations subject to FDA 21 CFR part 11 regs, but nothing that has anything to do with Sage products. 

Jeff Mack

Integrated Computer Systems

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