Verlag: Royal Society of Chemistry, 2018
ISBN 10: 178801281X ISBN 13: 9781788012812
Sprache: Englisch
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Verlag: Royal Society of Chemistry, 2018
ISBN 10: 178801281X ISBN 13: 9781788012812
Sprache: Englisch
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Verlag: Royal Society of Chemistry, 2018
ISBN 10: 178801281X ISBN 13: 9781788012812
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Verlag: Royal Society of Chemistry, 2018
ISBN 10: 178801281X ISBN 13: 9781788012812
Sprache: Englisch
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In den WarenkorbHRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.
Verlag: Royal Society of Chemistry, 2018
ISBN 10: 178801281X ISBN 13: 9781788012812
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Verlag: Royal Society of Chemistry, 2018
ISBN 10: 178801281X ISBN 13: 9781788012812
Sprache: Englisch
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Verlag: Royal Society of Chemistry, 2016
ISBN 10: 1849736626 ISBN 13: 9781849736626
Sprache: Englisch
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In den WarenkorbBuch. Zustand: Neu. Neuware - Data integrity is the hottest topic in the pharmaceutical industry. Global regulatory agencies have issued guidance, after guidance after guidance in the past few years, most of which does not offer practical advice on how to implement policies, procedures and processes to ensure integrity. These guidances state what but not how. Additionally, key stages of analysis that impact data integrity are omitted entirely.The aim of this book is to provide practical and detailed help on how to implement data integrity and data governance for regulated analytical laboratories working in or for the pharmaceutical industry. It provides clarification of the regulatory issues and trends, and gives practical methods for meeting regulatory requirements and guidance. Using a data integrity model as a basis, the principles of data integrity and data governance are expanded into practical steps for regulated laboratories to implement. The author uses case study examples to illustrate his points and provides instructions for applying the principles of data integrity and data governance to individual laboratory needs. This book is a useful reference for analytical chemists and scientists, management and senior management working in regulated laboratories requiring either an understanding about data integrity or help in implementing practical solutions. Consultants will also benefit from the practical guidance provided.
Verlag: Royal Society of Chemistry, 2016
ISBN 10: 1849736626 ISBN 13: 9781849736626
Sprache: Englisch
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In den WarenkorbHRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.
Verlag: Royal Society of Chemistry, 2016
ISBN 10: 1849736626 ISBN 13: 9781849736626
Sprache: Englisch
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In den WarenkorbHRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.
Verlag: Royal Society of Chemistry, 2016
ISBN 10: 1849736626 ISBN 13: 9781849736626
Sprache: Englisch
Anbieter: Ria Christie Collections, Uxbridge, Vereinigtes Königreich
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In den WarenkorbBuch. Zustand: Neu. Neuware - 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.