Does FDA certify electronic systems and methods used to obtain electronic signatures?

No. FDA does not certify individual electronic systems and methods used to obtain
electronic signatures. Compliance with the provisions of part 11 is the basis for FDA’s
acceptance of any electronic signature system, regardless of the particular technology or
brand used. This approach is consistent with FDA’s policy in a variety of program areas.
For example, FDA does not certify manufacturing equipment used to make drugs or
medical devices.