Matt Jones - Chair, DIGIT Committee
From my previous knowledge, and current status, they want a listing of all systems used By the company for clinical research, especially anything that generates, holds or manipulates data required for submission. This is for reconstructability purposes. They also inspect those vendors so will want to tie in any systemic observations they see at multiple sponsors/ CROs.
In meetings with regulators I’ve been in attendance in the last few weeks, it’s been stressed that they want to be able to see every electronic system, not to look into the validation etc, but to inspect for compliance with GCP e.g. in an eISF, do the documents exist in a logical format, have they been reviewed by the investigator etc. They only start looking at the validation documentation if a system is particularly difficult to use, or poses a challenge to the timelines of their inspection.
They also require inspector access to those systems that replace paper based processes according to ICH GCP R2
I hope this helps, and please let me know if you need further help and guidance