If investigators are not required to be Part 11 Compliant, what should we tell the sponsors when they ask if we are Part 11 Compliant? It seems they are picking sites that are only Part 11 Compliant. Is there an FDA document that specifically states this to show sponsors?

Investigators are required to be 21 CFR Part 11 compliant. The FDA has stated that citations related to Part 11 would be issued as a result of failures around recordkeeping requirements as delineated in Predicate Rules (e.g., 21 CFR parts 50, 56, 312, and/or 812). While the agency is not presently inspecting directly for it, Part 11 compliance is still very much required.