ensuring data integrity, meeting business and regulatory requirements /
First Statement of Responsibility
R. D. McDowall
EDITION STATEMENT
Edition Statement
2nd edition
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
xliv, 733 pages :
Other Physical Details
illustrations ;
Dimensions
24 cm
SERIES
Series Title
RSC Chromatography Monographs
Volume Designation
No. 20
ISSN of Series
1757-7055
INTERNAL BIBLIOGRAPHIES/INDEXES NOTE
Text of Note
Includes bibliographical references and index
CONTENTS NOTE
Text of Note
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