Annex 11

The revised Annex 11 Computerised Systems Jan 2011 has been released.  Check out Eudralex copy here. The key points of Annex 11 are Has defined requirements for project and operational phase of system. Risk Management Clearly defines that hardware and software components as part of the computerised system. IT infrastructure qualification Electronic Record and Signature requirements Deadline for coming into operation: 30 June 2011 If your company needs assistance meeting these requirements please contact us.