Questions & Anwers on EU GMP Guideline Annex 11 "Computerised Systems" - chapters 1-2
| Since 30 June 2011 the industry has been to implement all requirements of Annex 11 "Computerised Systems" of the EU GMP Guideline. Within the context of the Conference on Computer Validation from 8 - 9 June 2011 in Mannheim, inspectors and industry experts have answered questions concerning the 17 chapters of Annex 11. You will find questions and answers on chapters 1 "Risk Management" and 2 "Personnel" below - answers were provided by Klaus Eichmüller, Regierung von Oberbayern (Local Administration of Upper Bavaria) and Dr. Jörg Schwamberger, Merck KGaA. URL : link |