Greetings! Is there any indication when the new Annex 11 will go into effect? Is this being seen by the validation industry as a boon to business? It seems like the EU is falling into the crevice the FDA did in 1997 with Part 11 if its passed in its current form. The added requirements will place quite a burden on industry resources. It should be interesting to see how this plays out.
The updated Annex 11 was issued on 14-Jan-2011. What are the differences between the existing Annex 11 and the updated Annex 11?
The updated Annex 11 goes into effect 30-June 2011.