EMEA: Public consultation on revisions of GMP Annex 11 on Computerized Systems

Public consultation on revisions of GMP Annex 11 on Computerized Systems and related changes in GMP Part I/ Chapter 4 on Documentation.

The Annex has been updated in response to the increased use of computerised systems and the increased complexity of these systems. Consequential amendments are also proposed for Chapter 4 of the GMP Guide (Documentation).

Comments period ended by 31 October 2008.

Open New Annex 11 DRAFT document