This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good  Manufacturing Practice (GMP) guide. Annex 11 is common to the member states of the European Union (EU)/European Economic Area (EEA) as well as to the participating authorities of the Pharmaceutical  Inspection Co-operation Scheme (PIC/S). The current version was issued in 2011 and does not give  sufficient guidance within a number of areas. Since then, there has been extensive progress in the use  of new technologies.