Articles that discuss the selection and validation of chromatography data systems (CDS) in the regulated analytical laboratory.
The following articles and book discuss the selection and validation of chromatography data systems in the regulated analytical laboratory.
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.