Lavoisier S.A.S.
14 rue de Provigny
94236 Cachan cedex
FRANCE

Heures d'ouverture 08h30-12h30/13h30-17h30
Tél.: +33 (0)1 47 40 67 00
Fax: +33 (0)1 47 40 67 02


Url canonique : www.lavoisier.fr/livre/chimie/validation-of-chromatography-data-systems-2nd-ed/mcdowall/descriptif_3614390
Url courte ou permalien : www.lavoisier.fr/livre/notice.asp?ouvrage=3614390

Validation of Chromatography Data Systems (2nd Ed.) Ensuring Data Integrity, Meeting Business and Regulatory Requirements RSC Chromatography Monographs Series

Langue : Anglais

Auteur :

Couverture de l’ouvrage Validation of Chromatography Data Systems

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.

Date de parution :

Ouvrage de 733 p.

Disponible chez l'éditeur (délai d'approvisionnement : 13 jours).

Prix indicatif 246,45 €

Ajouter au panier

Thème de Validation of Chromatography Data Systems :