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Validation of Chromatography Data Systems: Meeting Business And Regulatory Requirements - Couverture rigide
Synopsis
Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. 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. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements is ideal for the chromatographer working in analytical laboratories in the regulated pharmaceutical, contract research, biotechnology and medical device industries seeking the practical guidance required for validating their chromatography data systems in order to meet regulatory requirements. It will also be welcomed by consultants or those in regulatory agencies.
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Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements: 11 (RSC Chromatography Monographs, Volume 11)
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Royal Society of Chemistry 00/b /07 F, 2005
ISBN 10 : 085404969X
ISBN 13 : 9780854049691
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Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements: 11 (RSC Chromatography Monographs, Volume 11)
Edité par
Royal Society of Chemistry 00/b /07 F, 2005
ISBN 10 : 085404969X
ISBN 13 : 9780854049691
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Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements (RSC Chromatography Monographs, Volume 11)
Edité par
Royal Society of Chemistry, 2005
ISBN 10 : 085404969X
ISBN 13 : 9780854049691
Ancien ou d'occasion
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Validation Of Chromatography Data Systems (Rsc Chromatography Monographs)
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Royal Society of Chemistry, 2005
ISBN 10 : 085404969X
ISBN 13 : 9780854049691
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Validation Of Chromatography Data Systems (Rsc Chromatography Monographs)
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Royal Society of Chemistry, 2005
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ISBN 13 : 9780854049691
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Validation Of Chromatography Data Systems (Rsc Chromatography Monographs)
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Royal Society of Chemistry, 2005
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ISBN 13 : 9780854049691
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Validation of Chromatography Data Systems
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Validation of Chromatography Data Systems
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Royal Society of Chemistry, 2005
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Validation of Chromatography Data Systems
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Validation Of Chromatography Data Systems: Meeting Business And Regulatory Requirements
Edité par
Royal Society of Chemistry, 2005
ISBN 10 : 085404969X
ISBN 13 : 9780854049691
Neuf
Couverture rigide
Vendeur : Basi6 International, Irving, TX, Etats-Unis
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Etat : Brand New. New. US edition. Expediting shipping for all USA and Europe orders excluding PO Box. Excellent Customer Service. N° de réf. du vendeur ABEJUNE24-138462
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