General requirements (11​.100)

There are a number of electronic signature requirements a system must meet to be Part 11 compliant. These requirements are intended to provide evidence and confidence the electronic signatures in the system can be considered the equivalent of handwritten signatures. The general requirements are:

• 11.100 (a): Electronic signatures must be unique to an individual

• 11.100 (b): Organizations must verify an individual's identity before the individual can use electronic signatures

• 11.100 (c): Persons using electronic signatures must certify to the FDA their electronic signatures are intended to be the legal equivalent of their handwritten signature