Handwritten signature

Under Part 11, a signature drawn with a stylus on a screen is still a handwritten signature, not an electronic signature. It must, however, be linked to its electronic record so it cannot be copied or removed.

(8) Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.

21 CFR, 11.3