Validation of Chromatography Data Systems

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