Validation of Chromatography Data Systems
Ensuring Data Integrity, Meeting Business and Regulatory Requirements
2nd Edition
Published on 25. November 2016
Book
Hardback
733 pages
978-1-84973-662-6 (ISBN)
Description
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.
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.
More details
Series
Edition
2nd edition
Language
English
Place of publication
Cambridge
United Kingdom
Target group
College/higher education
Professional and scholarly
Edition type
New edition
Product notice
Unsewn / adhesive bound
Dimensions
Height: 244 mm
Width: 159 mm
Thickness: 48 mm
Weight
1251 gr
ISBN-13
978-1-84973-662-6 (9781849736626)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Robert D. McDowall
Validation of Chromatography Data Systems
Ensuring Data Integrity, Meeting Business and Regulatory Requirements
E-Book
11/2016
2nd Edition
Royal Society of Chemistry
€246.99
Available for download
Robert D. McDowall
Validation of Chromatography Data Systems
Ensuring Data Integrity, Meeting Business and Regulatory Requirements
E-Book
11/2016
2nd Edition
Royal Society of Chemistry
€246.99
Available for download
Person
Content
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
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