| Document Type
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BL
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| Record Number
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730698
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b550464
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| Main Entry
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R.D. McDowall.
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| Title & Author
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Validation of chromatography data systems\ R.D. McDowall.
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| Publication Statement
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Cambridge: Royal Society of Chemistry, 2005
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| Page. NO
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200 pages ; 24 cm
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| ISBN
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085404969X
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: 9780854049691
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| Contents
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How to use this book; Introduction to Chromatography Data Systems; Regulatory Requirements for CDS Validation; Concepts of Computer Validation; CDS Validation: Managing System Risk; Process Redesign to Exploit the Tangible Benefits of Electronic Signatures with a CDS; Writing the User Requirements Specification (URS); Controlling the Work: The Validation Plan; System Selection; Auditing the CDS Vendor; Contract, Purchase Order and Planning the Installation; Risk Assessment and Requirements Traceability; Installation Qualification and Operational Qualification (IQ and OQ); Performance Qualification (PQ) or End User Testing; User Training and System Documentation; IT Support of the System; System Description; Validation Summary Report; Defining Electronic Records for a CDS; Maintaining the Validation Status during Operational Life; Periodic Review of the CDS; Records Retention; CDS Data Migration; CDS System Retirement; Retrospective Validation; References;
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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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| Added Entry
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R D McDowall
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Royal Society of Chemistry (Great Britain)
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