Validation Of Chromatography Data Systems: Meeting Business And Regulatory Requirements

This book consists of 26 chapters that cover the complete life cycle of a CDS in a regulated laboratory. Readers are introduced to the basics of computer validation. The book also looks in detail at the regulatory requirements throughout the life cycle of a CDS for any regulated laboratory, from its concept, through writing the user requirements specification to selecting the system, testing and operational release, including using electronic signatures.

Not only does the book provide background to regulatory requirements, interpretation of the regulations and documented evidence needed to support a claim that a system is validated, it is uniquely ordered to make using it extremely easy. I wrote this book so that users could go straight to an area of concern - no wading through chapters to figure out where the information you wanted could be found. Instead, I put things under very specific chapters, such as "Auditing the CDS Vender" and "Writing the User Requirements Specification", together with the applicable regulatory requirements so you can find exactly what you want quickly.

The cost is £79.95 (£53.00 for RSC members). To order online, visit the Royal Chemistry Society's web site at http://www.rsc.org/shop and search for either Validation of Chromatography Data Systems Meeting Business and Regulatory Requirements, by R D McDowall, or ISBN 0 85404 969 X.

Listed here are some example chapters.

• Preface, Table Of Contents And Lists Of Figures And Tables
  The detail of the book is listed here.
• Chapter 1: How To Use This Book
  This chapter is key to the whole book as it provides graphical roadmaps that describe individual chapters and how they link with others in the book. Each chapter is intended to stand alone so that a reader can either read a specific topic in isolation without having to wade through lots of detail.
• Chapter 6: Exploiting The Tangible Benefits Of Electronic Signatures
  What are the regulations for using electronic signatures and how should you implement electronic signatures in a CDS? The only way to implement electronic signatures is via a redesigned and electronic process not a paper based one. Using case study examples, the reader can understand how to implement electronic working and gain tangible business benefits at the same time.
• Chapter 7: Writing the User Requirements Specification (URS)
  This chapter is representative of the remainder of the chapters in the book. It starts with the regulations and regulatory guidance and an associated interpretation together with the business rationale for writing a URS. It lists the main sections that should be found in a URS. Writing good requirements is a goal to attain and the chapter concludes with the ways to archive this together with examples of how not to write requirements.

 Outline Prospectus And Order Form For The Book.