FDA 21 CFR Part 11, by Food and Drug Administration (FDA) of the US government, definesthe criteria under which electronic records and electronic signatures can be treated withsame degree of validity as paper-based records. Since the scope of FDA’s regulatoryauthority is very broad, Part 11 has an impact on all computer systems in life scienceindustry.… Read More How to comply with CFR 211 (FDA 21 CFR Part 11) when using a Maple Systems HMI