If you intend to use an electronic copy in place of the paper source data (i.e., intends to destroy the paper source data), then part 11 regulations would apply to the electronic system used to create the copy. 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. You should ensure that the integrity of the original data and the content and meaning of the record are preserved. 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.
