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 201

 

If your company needs assistance meeting these requirements please contact us.