Hi all,

I hope someone can advise or point me in the right direction?

We are looking at pursuing a vendor (as I've posted historically) which is purpose built for clinical research delivery. The system provides an eregulatory component (electronic site files) an eDel and eSource (visit specific data collection in in line with the protocol and edc).

The system is UK GDPR compliant, and goes as far as being EU Annex 11 compliant and 21 CFR 11 compliant...

But when it comes to signatures, can I assume if it does not meet UK Eidas /QES, then in reality the signatures are not compliant, at least from a UK point of view?

The system is called CRIO eSource if anyone has any experience with it.

Many thanks