For electronic systems owned or managed by sponsors and other regulated entities that fall under the scope of 21 CFR part 11, what will be FDA’s focus during inspections?

For these electronic systems that fall under the scope of part 11, an FDA inspection will
focus on the implementation of the electronic system, including changes made to the
system once in use and documentation of validation to test system functionality after
implementation, where applicable. During inspection, FDA will focus on any source
data that are transferred to another data format or system to ensure that checks are in
place and that critical data19 are not altered in value or meaning during the migration
process. FDA will also review standard operating procedures and support mechanisms in
place, such as training, technical support, and auditing to ensure that the system is
functioning and is being used in the manner intended.