Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements (RSC Chromatography Monographs) by Robert McDowall

by R.D. McDowall

"Validation of Chromatography Data Meeting Business and Regulatory Requirements introduces the basics of computer validation. It looks in detail at the 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." This logical and uniquely organised book provides the background to the regulatory requirements, interpretation of the regulations and documented evidence needed to support a claim that a system is validated. Development of the system, risk management, operation and finally system retirement and data migration are discussed. Case studies and practical examples are provided where appropriate.

Hardcover

First published February 7, 2005