The following documents and articles have been published by Kereon AG or in collaboration with the mentioned organizations:

• Cloud computing : how to choose the right cloud supplier
  co-writing with Robert (Bob) McDowall, McDowall Consulting
  Spectroscopy, December 2013
• Cloud computing for regulated "GxP" environments (English version),
  GMP Journal
  - Part 1: October/November 2012
  - Part 2: April/May 2013
  Concept Heidelberg
• Cloud computing for regulated "GxP" environments (German version),
  GMP Journal
  - Part 1: October/November 2012
  - Part 2: January/February 2013
  Concept Heidelberg
• Supplier involvement and supplier audit - From theory to practice
  pharmind, 02/2012
  (Editio Cantor Verlag)
• New Annex 11: Evolution et consequences
  Pharma, January/February 2012, Volume 8-1, Via Media UK Ltd
• Evolution: New Annex 11 supports a risk-based approach
  GMP Journal, October/November 2011, Concept Heidelberg
• Evolution: New Annex 11 supports a risk-based approach (German text)
  GMP Journal, July/August 2011, Concept Heidelberg
• New Annex 11: evolutions and consequences , May 2011
  A3P
• GAMP® 5: A risk-based approach to compliant GxP computerized systems
  Realization of the French version, ISBN 1-931879-95-8
  (in collaboration with and for ISPE)
• Supplier involvement and supplier audit Computerized System Validation within GxP regulated environments: Implementating GAMP® and current trends
  pharma technologie journal, 2010, ISBN 978-3-87193-412-4
  (Editio Cantor Verlag)
• Risk-based approach: time and cost efficient planning and validation
  Pharma+Food, 2004, June
  (Hüthig Verlag)
• Country profile Switzerland
  Pharmaceutical Engineering, 2004, January/February
  (bi-monthly publication for ISPE members)
• Good Practice Guide: Calibration Management
  Consolidation and finalization of the French translation
  (in collaboration with and for ISPE)
• GAMP® 4: Guide for Validation of Automated Systems
  Consolidation and finalization of the French translation of GAMP® 4
  (in collaboration with and for ISPE)

In the context of ISPE and GAMP Forum activities, Kereon AG took part in the elaboration of the Good Practice Guide about IT Infrastructure:

• GAMP® 5: A risk-based approach to compliant GxP computerized systems
  February 2008, ISPE
• GAMP® Good Practice Guide: IT Infrastructure Control and Compliance
  September 2005, ISPE

Presentation list

Information