How to validate your CDS

Abstract

This is a quite specialised, rather unique text that focuses on the particular problems associated with validation of chromatography data systems (CDSs). In the preface, the author clearly defines the target audience and objectives of the text with the following statement: “If you are using a chromatography data system in the regulated areas of the pharmaceutical, medical device, active pharmaceutical ingredient and contract research organisations, you will need to validate the system. This book will be your guide through the regulations and jargon. It 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.” There are 25 chapters that range from introductory material on CDSs, regulatory requirements, computer validation and managing system risk, to implementation issues that cover user specification, planning, system selection, purchase and installation, and user training, and then to performance and review issues, and records management. The book is very detailed and is full of very practical advice and recommendations, useful flow charts and definitions that will all be extremely valuable for any person charged with responsibility for implementing such a CDS. I have not seen any previous text that covers this particular territory, so I have no doubts whatsoever that the book will be of great importance to those faced with the task of understanding regulatory requirements and then selecting and installing a CDS having the required capability. I found the book to be well laid out, to be easy to read and to be very systematic in its approach. My only minor criticism is that the subject index is very brief and this makes it somewhat difficult to locate specific parts of the book. However, the topic is such that a reader will normally need to read the entire book rather than to consult parts of it selectively. If you are involved in chromatography in the above-mentioned regulated areas, then this book will be an excellent resource.