Yes. Using an electronic means, such as a durable electronic storage device is an
acceptable method to archive study-related records at the end of the study. Sponsors and
other regulated entities should ensure that the integrity of the original data and the content
and meaning of the record are preserved. In addition, if the electronic records are
archived in such a way that the records can be searched, sorted, or analyzed, sponsors and
other regulated entities should provide electronic copies with the same capability to FDA
during inspection if it is reasonable and technically feasible. During inspection, FDA
may request to review and copy records in a human readable form using electronic
system hardware.