Dear All,
GxP courses - pdf documents, SOP, policies etc are hosted on PDHQ and Veeva vaults.
As a part of SF iContent server is utilised to host course video files. The video files are pulled into few of the GxP courses as examples or to coach the audience in few scenarios.
Two Questions - related to ITQA companies who are governed by FDA regulations.
1) Would you classify the video files associated to courses as Electronic record?
In other words, GxP courses are using video files hosted on SF iContent server - would you classify these video files as an electronic record since it is linked to a course?
2) Would you classify iContent Server as validated or non-validated.
Remember all courses on iContent server are video files.
Happy to connect separately to discuss since this requires a broader discussion.
Thanks
Khalid
