The goal of a fresh draft guidance...

The goal of a fresh draft guidance about 21 CFR 11 is to provide information about FDA's popular thinking on acceptable ways of meeting requirements to make secure that electronic records and electronic signatures are trustworthy, reliable, and compatible with FDA's public health responsibilities (www.fda.gov/cber/gdins/esigcopies.pdf). The draft guidance focuses in succession how to provide FDA with electronic copies of electronic records that are accurate, ended and suitable for FDA inspection, review, and copying. The draft guidance also addresses attributes of like electronic copies that ...