Instead of continuing to ask for examples, I'm feeling inclined to provide one when I think it might be useful! :)

I'm curious as to some of the entries listed. I have helped assemble a few DHFs but I have not included some of the things listed; e.g., kick-off meeting minutes, business analysis, etc. These are good and useful things but I don't see they are necessarily relevant for the DHF.

Then again, if it works for you and you have no audit findings, it's gold! :)

Yodon-Excellent Point! My intent here was to "align" the document requirements in the Design Plan to eliminate confusion as to what is/isn't required in the DHF. I'll take the (FDA) risk in supplying too much in the DHF. It's the converse I'm trying to avoid!