Overview

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.

Full Product Details

Author:   Robert D McDowall (Director, R.D.McDowall Ltd) ,  Roger Smith
Publisher:   Royal Society of Chemistry
Imprint:   Royal Society of Chemistry
Edition:   2nd edition
Volume:   Volume 20
Dimensions:   Width: 15.60cm , Height: 4.60cm , Length: 23.40cm
Weight:   1.344kg
ISBN:  

9781849736626

ISBN 10:   1849736626
Pages:   733
Publication Date:   25 November 2016
Audience:   College/higher education ,  Professional and scholarly ,  Postgraduate, Research & Scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

How To Use This Book; What is a CDS and its Evolution; Laboratory Informatics and the Role of a CDS; Applicable GXP Regulations and Guidance; Concepts of Computer Validation; Understanding Life Cycles and SW Classification; CDS Data Integrity; CSV Risk Management: System Risk; Working Electronically; Specifying User and System Requirements; Controlling the Validation; System Selection; Auditing the Supplier; Negotiating the Contract and System Purchase; Planning the Installation; CSV Risk Management; Importance of the Traceability Matrix; Writing the Configuration Specification; Writing the Technical Specification; Installing and Integrating System Components; Designing the Test Suite; Writing Test Cases; Executing Test Scripts; User Training and System Documentation; IT Support; System Description; Defining CDS Raw Data and E-Records; Validation Summary Report; Integration in a Regulated Environment; User Account Management; Incident and Problem Management; Change Control and Configuration Management; On-Going IT Support; Conducting a Periodic Review; CDS Records Retention; System Retirement; Data Migration Options; Retrospective Validation

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