Robert D McDowall

Validation of Chromatography Data Systems

Ensuring Data Integrity, Meeting Business and Regulatory Requirements

• Gebundenes Buch

Produktbeschreibung

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.

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Produktdetails

• Verlag: RSC Publishing
• 2nd edition
• Seitenzahl: 733
• Erscheinungstermin: 25. November 2016
• Englisch
• Abmessung: 244mm x 159mm x 48mm
• Gewicht: 1251g
• ISBN-13: 9781849736626
• ISBN-10: 1849736626
• Artikelnr.: 45465172

Inhaltsangabe

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