Name: EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP (en Inglés)
Price: 398270.00 CLP
Availability: InStock
Author: Lopez, Orlando
ISBN: 9781482243628

portada EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP (en Inglés)

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP (en Inglés)

Formato

Libro Físico

Autor

Orlando Lopez

Editorial

CRC Press

Idioma

Inglés

N° páginas

379

Encuadernación

Tapa Dura

Dimensiones

25.7 x 18.0 x 2.5 cm

Peso

0.84 kg.

ISBN13

9781482243628

Categorías

Farmacología
Seguridad informática

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP (en Inglés)

Orlando Lopez (Autor) · CRC Press · Tapa Dura

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Reseña del libro "EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP (en Inglés)"

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 use of computer systems. EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP supplies practical information to facilitate compliance with computer system GMP requirements, while highlighting and integrating the Annex 11 guidelines into the computer compliance program. The ideas presented in this book are based on the author's 25 years of experience with computer validation in the healthcare industry with various computer systems development, maintenance, and quality functions. The book details a practical approach to increase efficiency and to ensure that software development and maintenance are achieved correctly. Examining the implementation of the computer systems validation entirely based on EU Annex 11, the book includes examples from laboratory, clinical, and manufacturing computer systems. It also discusses electronic record integrity associated with stored information.