Other projects in the field of system validations have been carried out:

  • 2015 - Support of a software company by introducing their product in the regulated environment
  • 2013 - Further development of a Learning Management System (LMS as SaaS) and rollout for other departments
  • 2012 - System Selection of a Document Management System as replacement for an existing DMS under GxP
  • 2010 - Support for the preparation of an FDA Audit
  • 2009 - Audit of production control at a chemical manufacturer for the pharmaceutical industry
  • 2008-2009 - Support of the validation during an eCTD Introduction
  • 2008-2009 - The harmonization of SOPs and templates for CSV in an international pharmaceutical company
  • 2008 - Validation of an IT centralization with virtualization and the introduction of a mirrored electronic archiving system
  • 2007-2008 - Centralization of IT virtualization in GxP environments
  • 2007 - Training and coaching in the implementation of a global IT-QA
  • 2005-2008 - Various audits of software vendors
  • 2005-2006 - Validation of a document management system for SOP management and distribution of a chemical manufacturer
  • 2002-2005 - Project manager for international DMS in Regulatory Affairs and Production in a crop protection group