TABLE OF CONTENTS Chromatography is a major analytical technique that is used in almost all analytical laboratories. The days of chart recorders and paper and pencil interpretation have gone and today the chromatography data generated by a method is now acquired, stored, interpreted, manipulated and reported by a chromatography data system (CDS).
When a laboratory operates in a controlled industry, such as the pharmaceutical, biotechnology or medical device along with the allied contract research organisations, the applicable regulations require that the CDS be validated for its intended purpose. However, in today s world where many organisations work in a global market, there are many regulations that are applicable even within a single laboratory.
The purpose of this book is to give readers a practical understanding of how to validate their CDS. The principles outlined here are applicable from single standalone systems to client server systems for a site and to larger terminal served systems operating between sites and over two or more time zones. The reader needs to scale the principles in this book to their specific system and ways of working.
Analytical laboratories working in analytical research and development and manufacturing under Good Manufacturing Practice (GMP) regulations as well as bioanalytical laboratories operating under Good Laboratory Practice (GLP) regulations can use this book. This book also includes validation of mass spectrometry data systems used for quantitative analysis in a regulated environment.
In this book, I want to discuss the prospective validation of CDS software. By prospective validation, I mean...
