Don't know if I'm posting this in the right spot?
Okay I have a question for you that I was hoping you could give me some insight or direct me to a location where I could get some help on this. The scope of our registration is with an analytical scanner which is used in unison with software developed here at our company. The big issue I have with this is surrounding the DHF and how to continually update or revise the DHF because this software is continually expanding. To give you an example the first four platforms we launched were for products A, B, C, & D with specific installers and templates within the software. Now we are adding products E & F to this which is are additional platforms but the installers and templates are different for this. The original 4 were a version 1.0 and now with products E & F it is version 2.0, but again have additional features that are not included on the original 4 platforms. They are all based upon the same scope but trying to figure our how to manage the DHF with these type of changes is difficult at best because your not changing everything. I thought it best to create separate DHF's for these but my regulatory body suggests keeping it all in one DHF because they are all covered under the scope of the initial product. Is there anything you could give me to help with this or direct me to some sources that I could get some additional help with this?