Validation of Chromatography Data Systems : Ensuring Data Integrity, Meeting Business and Regulatory Requirements

Mcdowall, Robert; Smith, Roger (EDT)

ISBN 10: 1849736626 / ISBN 13: 9781849736626

Editore: Royal Society of Chemistry, 2016

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Codice articolo 28615420

Dati bibliografici

• Titolo: Validation of Chromatography Data Systems : Ensuring Data Integrity, Meeting Business and Regulatory Requirements
• Editore: Royal Society of Chemistry
• Data di pubblicazione: 2016
• Lingua: Inglese
• ISBN 10: 1849736626
• ISBN 13: 9781849736626
• Rilegatura: Rilegato
• Edizione: seconda edizione
• Condizione: As New

Descrizione articolo

Riassunto

Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate.

The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer’s book shelf.