ABSTRACT
The Eudralex Volume 4, Annex 11, which refers specifically to computer systems and information technology (IT) infrastructure, provides guidance for the interpretation of the above requirement for all EU Member States, the three European Economic Area (EEA) states, and Switzerland. Annex 11 is found in Volume 4 of “The rules governing medicinal products in the European Union.” Volume 4 includes the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Parts I, II, and III and the Annexes.
