Validation of chromatography data systems : ensuring data integrity, meeting business and regulatory requirements / R.D. McDowall, R.D. McDowall Ltd., Bromley, UK.

Format:

Book

Author/Creator:

McDowall, R. D., author.

Series:

RSC chromatography monographs ; 20.

RSC chromatography monographs, 1757-7055 ; number 20

Language:

English

Subjects (All):

Chromatographic analysis.

Computer software--Validation.

Computer software.

Physical Description:

1 online resource (778 pages) : illustrations.

Edition:

Second edition.

Place of Publication:

Cambridge : Royal Society of Chemistry, [2017]

Summary:

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.

Contents:

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.

Notes:

Includes bibliographical references and index.

Description based on online resource; title from PDF title page (ebrary, viewed January 3, 2017).

ISBN:

9781523126293

1523126299

9781782624073

1782624074