| Document Type
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BL
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| Record Number
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648273
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| Doc. No
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dltt
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| Main Entry
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McDowall, R. D.
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| Title & Author
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Validation of chromatography data systems : : ensuring data integrity, meeting business and regulatory requirements /\ R. D. McDowall
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| Edition Statement
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2nd edition
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| Series Statement
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RSC Chromatography Monographs; No. 20
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| Page. NO
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xliv, 733 pages :: illustrations ;; 24 cm
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| ISBN
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1849736626
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: 9781849736626
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9781782624073
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9781782629801
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| Bibliographies/Indexes
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Includes bibliographical references and index
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| Contents
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How to use this book -- What is a CDS? The past, present and future -- Laboratory informatics and the role of a CDS -- Applicable GXP regulations and guidance for CSV -- Concepts of computer validation -- Understanding software categories and system life cycles -- Ensuring data integrity for chromatography data systems -- CDS validation: managing system risk -- Working electronically and using electronic signatures -- Writing the user and system requirements -- Controlling the validation -- System selection -- Assessing the CDS supplier -- Negotiating the contract and purchasing the system -- Planning the installation of the system -- CSV risk management requirements level assessment -- Importance of the traceability matrix -- Writing configuration specifications -- Writing the technical specification -- Installing and integrating system components -- Designing the user acceptance test suite -- Writing test scripts and test cases -- Executing test scripts and reporting the results -- User training and system documentation -- IT support for a CDS -- System description -- Defining electronic records and raw data for a CDS -- Writing the validation summary report -- Integration in a regulated environment -- User account management -- Incident and problem management -- Change control and configuration management -- Periodic review of the CDS -- CDS records retention -- CDS system retirement -- CDS data migration -- Retrospective validation
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| Subject
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Chromatographic analysis
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| Subject
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Computer software-- Validation
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| LC Classification
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QD79.C4.M33 2017
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