Pharmaceutical computer systems validation quality assurance risk management and regulatory compliance hardcover feb 23 2010 by guy wingate editor 43 out of 5 stars 8 ratings see all 6 formats and editions. Pharmaceutical computer systems validation quality assurance risk management and regulatory compliance ebook wingate guy amazonca kindle store. Computer systems validation quality assurance risk management and regulatory compliance for pharmaceutical and healthcare companies wingate guy 9780849318719 books amazonca. Key topics in pharmaceutical computer systems validation second edition include gamp5 astm 2500 eu gmp annex 11 and us gmp revisions to regulatory requirements for electronic records and signatures that should be published in 2008 ich guidance q8 q9 and q10 expectations fda cgmps for the 21st century initiative and associated guidance. Systems validation quality assurance risk management and regulatory compliance second edition edited by guy wingate glaxosmithkline barnard castle uk informa healthcare new york london contents foreword to the second edition vii foreword to the first edition viii preface xi contributor biographies xiii abbreviations xx contributors xxxii 1 introduction 1 2 organization and management 18