This document provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of medical products, foods,tobacco products, and new animal drugs.
The guidance provides recommendations regarding the requirements under 21 CFR part 11 (part 11), pursuant to which FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures10
executed on paper