EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

by Orlando Lopez

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Book cover for EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

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Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is
  • ISBN13 9781482243635
  • Publish Date 6 April 2015
  • Publish Status Active
  • Out of Print 21 April 2015
  • Publish Country GB
  • Publisher Taylor & Francis Ltd
  • Imprint CRC Press
  • Format eBook
  • Pages 379
  • Language English