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

Orlando Lopez, Markus Roemer




[PDF.xi78] EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

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 | #3801790 in Books |  2015-04-06 | Original language:English | PDF # 1 |  1.00 x7.10 x10.10l,.0 | File type: PDF | 379 pages

||About the Author||Orlando López |Data Integrity SME |Durham North Carolina USA | |Orlando has worldwide pharmaceutical experience with relevant work in computer systems regulatory requirements including US, EMA, Australian, Japanese, W

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 to provide the EMA healthcare industry with consistent criteria for effective implementation, control, and us...

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