Validation of Chromatography Data Systems

Validation of Chromatography Data Systems

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Validation of Chromatography Data Systems: 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.Sample History Modified Vial(Batch_Numbers): alt;No Valueagt; -agt; 57844/3 User: HLongden Date: 23/01/2003 16:02:05 Reason: Sample / Standard values entered incorrectly Modified Vial(ColumnlD): alt;No Valuer -agt; 1 2345/a Modified Vial(Column_Type): AlNo Valueagt; -agt; Xterra C18 1 x 50 ... Here, an automatically fitted peak is in capital letters while manually integrated peaks have one or both baselineanbsp;...

Title:Validation of Chromatography Data Systems
Author:R. D. McDowall
Publisher:Royal Society of Chemistry - 2005-01-01


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