System 800xA automation technology facilitates compliance with FDA 21 CFR Part 11 and integrates electronic records and electronic signatures as core system functions.
One of the most recent regulations relevant top pharmaceutical manufacturing is 21 CFR Part 11, issued by the U.S. Food and Drug Administration. This rule applies to all products manufactured in the United States, and also to products manufactured elsewhere but distributed in the United States, which gives it international relevance.