Hi!  We have not done this yet, but it is on our wish list.  I am not sure I can provide much discussion info yet, as our next X3 project is moving to version 11 and that is keeping me quite busy.  But after the first of the year, would be interested in discussing what is needed to accomplish this.

Lisa Ziomkowski

Oregon's Wild Harvest

Hi! I went through a project including CFR Part 11 validation 12 years ago for a french company selling pharmaceutics products in the US. The entire validation process has been driven by the customer and with the support of an external audit company.

The impact for us (the integration team) was some very advanced discussions on Sage X3 functionalities regarding password management, audit trail, workflows, users rights, .... At the end, we did lots of specific developments and documentations.

What I understood from this experience that you don't validate a tool but a process. So any controls or information missing in the system can be done with manual processes to make it works. For instance, they are using scales and they have to prove the scale is properly calibrated, they finally decided to track the calibration process with signature in a paper book and not in the system.

So practically you can expect to spend some days to discuss about Sage X3 features and build lots of documentations. Unfortunatly, I don't think they are still using X3 nowdays.

Hello Lisa,

CFR 21/11 Validation can be tricky.  It is typically associated with company processes, however, security and audit might be something to consider.  An example might be "change reason codes" and "electronic signatures".  Your industry might require that specific entry screens provide an additional layer of security that monitors field level changes.  This is extreme, but, X3 might have a few tools that can assist with this effort.

Perhaps further discussion would be helpful?  Let me know.

Best,

Tom