GAMP Good Practice Guide: Operation of GxP Computerized Systems (German Translation)

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Title:

GAMP Good Practice Guide: Operation of GxP Computerized Systems (German Translation)

Author(s):

Alexander, Karen; Cappucci, Winnie; Lawrence, Pam; Lewis, Scott; Loscombe, Christopher; Mafemba, Munya; Reid, Chris; Harrison, Elizabeth; Samways, Kate; Sanders, Genni; Stafford, James; Stephenson, Rob; Topham, Simon; Wakeham, Charlie

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Author(s): Alexander, Karen; Cappucci, Winnie; Lawrence, Pam; Lewis, Scott; Loscombe, Christopher; Mafemba, Munya; Reid, Chris; Harrison, Elizabeth; Samways, Kate; Sanders, Genni; Stafford, James; Stephenson, Rob; Topham, Simon; Wakeham, Charlie

During the operational life of a GxP system regulators usually focus on the integrity, consistency, and completeness of controls required to maintain compliance. This Guide highlights the importance of the operation phase of the system lifecycle, when the return on investment for the significant time and resource expended in implementing new computerized systems can be achieved. The Guide will help regulated organizations achieve regulated computerized systems that are fit for intended use and compliant with applicable regulations and provides comprehensive guidance for maintaining control of regulated systems throughout their operational life.

Table of Contents

GAMP Good Practice Guide: Operation of GxP Computerized Systems (German Translation)

Full Title: ISPE GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems
Pages: 216
Published: 2010-11-08

Table of Contents pages: 1 2

Table of Contents pages: 1 2