A five part series on Chromatography Data Systems published in LC-GC Europe during 1999-2000 covering: The Fundamentals, Specifying And Selecting A System, Validating The System, Managing Change In A Changing World and Data Migration And System Retirement.
General articles about Chromatography Data Systems (CDS), including information on A/D Converters, the use of CDS in Combinatorial Chemistry Laboratories and considerations when validating a CDS.
Retrospective Validation Of A CDS. Prospective Validation Of A Mass Spectrometry Data System Used In Quantitative GLP Studies. Data Migration Of Mass Spectrometry Data Between Platforms And Applications. Cost Beneficial Validation Of A Site CDS.
A Questions Of Quality Paper. Exploiting The Benefits Of Electronic Signatures With A Chromatography Data System.
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.