About this product

Product Identifiers

PublisherRoyal Society of Real Chemistry, T.H.E.

ISBN-101849736626

ISBN-139781849736626

eBay Product ID (ePID)227848188

Product Key Features

Number of Pages733 Pages

LanguageEnglish

Publication NameValidation of Chromatography Data Systems : Ensuring Data Integrity, Meeting Business and Regulatory Requirements

SubjectScientific Instruments, Chemistry / Analytic, Research & Methodology

Publication Year2016

FeaturesNew Edition

TypeTextbook

Subject AreaScience

AuthorRobert D. Mcdowall

SeriesRsc Chromatography Monographs

FormatHardcover

Dimensions

Item Weight47.4 Oz

Item Length9.2 in

Item Width6.2 in

Additional Product Features

Edition Number2

Intended AudienceScholarly & Professional

LCCN2016-499758

Dewey Edition23

Series Volume NumberVolume 20

IllustratedYes

Dewey Decimal543/.80285

Edition DescriptionNew Edition

Table Of ContentHow 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

SynopsisGuiding chromatographers working in regulated industries and helping to validate their chromatography data systems to meet both business and regulatory needs, this book will be a detailed look at the requirements to ensure a system is fit for purpose throughout the life cycle. The work is divided into four parts, initially providing a background to the regulatory requirements and documented evidence needed to support a claim that a system is validated. Development of the system, operation and finally retirement are then all discussed in detail with case studies and practical examples provided as appropriate., 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., 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.

LC Classification NumberQD79.C4