TABLE OF CONTENTS Chromatography is an analytical technique used in virtually all sectors of the pharmaceutical, medical device and biotechnology industries to detect or quantify compounds during the course of product development and manufacture. It can be used for the assessment of active ingredients, raw materials, impurities and determining the stability of active in final preparations. The chromatograms generated by these analytical methods are displayed, integrated and results calculated by a software application called a Chromatography data system (CDS).
This section discusses the operation of a CDS from the perspective of a typical laboratory process or workflow. Figure 4 shows the main features of a CDS and Figure 5 shows the overall sequence of events that a typical data system should perform. This is a generalised approach to the operation of a typical data system; further details on the subject are the Royal Society of Chemistry monograph by Dyson,3 the book by Fellinger on Data Analysis and Signal Processing in Chromatography4 and in the chapter and articles by McDowall.5 ,6
This understanding is important as detailed knowledge of how a specific CDS application works is essential to write and maintain a user requirements specification throughout the operational lifetime of any system.
A CDS can come in one of the following types:
integrator (single user and single instrument...
