11 April 2008
European Commission:
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 should be sent to entr-gmp@ec.europa.eu and
GMP@emea.europa.eu by 31 October 2008.
GMP Annex 11 on Computerized Systems
GMP Part I/ Chapter 4 on Documentation
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