The continued evolution of electronic systems has caused us all, including the Food and Drug Administration (FDA) to have to scramble to keep up with changes. The FDA recently released a draft guidance titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers. While this guidance is not final, it may provide some insight as to how the FDA now views issues related to electronic systems. Note also that the FDA is accepting comments on the draft guidance through May 15th. Click on the link above to read the draft guidance and/or submit a comment to the FDA.