Hi,

As part of my company's inspection preparations we have been updating our MHRA GCP inspection dossier and have come across differences of opinion with reference to completion of section 1, item 3 - Computer Systems. The differences stem from the company being mostly virtual with several vendors providing services which has led to differing theories as to what needs to be included in this section. These range from just the systems the company directly manages to every single system involved in our studies including those that were implemented and are managed by external parties (e.g. EDC).

Does anyone have experience/an opinion on this?

Many thanks.