Validation of Chromatography Data Systems

Validation of Chromatography Data Systems
 
Author:
R. D. Mc Dowall
Release at: 2017
Pages: 776
Edition:
Second Edition
File Size: 16 MB
File Type: pdf
Language: English


Description of Validation of Chromatography Data Systems


Why read or even buy this Why read or even buy this book? If you are using this Validation of Chromatography Data Systems book in the regulated areas of the pharmaceutical, medical device, active pharmaceutical ingredient, and contract research organizations, you will need to validate the system. This Validation of Chromatography Data Systems book will be your guide through the regulations and jargon. 

This Validation of Chromatography Data Systems book provides practical advice that can be used directly by you to meet regulatory requirements and allow a sustainable validation effort for your chromatography data system throughout its operational life. book? If you are using this Validation of Chromatography Data Systems book in the regulated areas of the pharmaceutical, medical device, active pharmaceutical ingredient, and contract research organizations, you will need to validate the system. 

This Validation of Chromatography Data Systems book will be your guide through the regulations and jargon. This Validation of Chromatography Data Systems book provides practical advice that can be used directly by you to meet regulatory requirements and allow a sustainable validation effort for your chromatography data system throughout its operational life.

The importance of validation of laboratory computerized systems operating in regulated laboratories has not changed and is indeed become more important since the publication of the first edition of this book. Since 2005, there has been a detection of increased fraud and falsification involving chromatography data systems, as evidenced in FDA warning letters and citations by other regulatory authorities. 

Coupled with this, are poor data management practices that have also resulted in increased regulatory scrutiny of these systems as often chromatographic analysis can constitute up to 100% of a GXP regulated laboratory’s workload. This results in the detailed examination of the system: the validation, change control as well as the integrity of the electronic records/raw data generated.

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