Guiding chromatographers working in regulated industries and helping to validate their chromatography data systems, this book will be a detailed look at the requirements to ensure a system is fit for purpose throughout the life cycle.
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Vendeur : GreatBookPrices, Columbia, MD, Etats-Unis
Etat : New. N° de réf. du vendeur 28615420-n
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Vendeur : Rarewaves USA, OSWEGO, IL, Etats-Unis
Hardback. Etat : New. 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. N° de réf. du vendeur LU-9781849736626
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Vendeur : PBShop.store US, Wood Dale, IL, Etats-Unis
HRD. Etat : New. New Book. Shipped from UK. Established seller since 2000. N° de réf. du vendeur CW-9781849736626
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Vendeur : GreatBookPricesUK, Woodford Green, Royaume-Uni
Etat : New. N° de réf. du vendeur 28615420-n
Quantité disponible : 14 disponible(s)
Vendeur : GreatBookPrices, Columbia, MD, Etats-Unis
Etat : As New. Unread book in perfect condition. N° de réf. du vendeur 28615420
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Vendeur : Grand Eagle Retail, Bensenville, IL, Etats-Unis
Hardcover. Etat : new. Hardcover. 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 chromatographers book shelf. Guiding chromatographers working in regulated industries and helping to validate their chromatography data systems, this book will be a detailed look at the requirements to ensure a system is fit for purpose throughout the life cycle. Shipping may be from multiple locations in the US or from the UK, depending on stock availability. N° de réf. du vendeur 9781849736626
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Vendeur : PBShop.store UK, Fairford, GLOS, Royaume-Uni
HRD. Etat : New. New Book. Shipped from UK. Established seller since 2000. N° de réf. du vendeur CW-9781849736626
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Vendeur : Ria Christie Collections, Uxbridge, Royaume-Uni
Etat : New. In. N° de réf. du vendeur ria9781849736626_new
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Vendeur : Rarewaves.com USA, London, LONDO, Royaume-Uni
Hardback. Etat : New. 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. N° de réf. du vendeur LU-9781849736626
Quantité disponible : 3 disponible(s)
Vendeur : GreatBookPricesUK, Woodford Green, Royaume-Uni
Etat : As New. Unread book in perfect condition. N° de réf. du vendeur 28615420
Quantité disponible : 14 disponible(s)