In January 2011 the European Commission (EudraLex) released Annex 11 Computerised Systems (revision 1) which comes in to effect on 30 June 2011.
This has been a long awaited release of the GMP Guideline for Computerised Systems which was first issued for comment in April 2008 for public consultation. The final release of Annex 11 has been reduced considerably to that put out for public
Friday, 11 February 2011
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