Robert McDowall

Validation of Chromatography Data Systems (eBook, PDF)

Meeting Business and Regulatory Requirements

• Format: PDF

Produktbeschreibung

Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements introduces the basics of computer validation. It looks in detail at the requirements throughout the life cycle of a CDS for any regulated laboratory, from its concept, through writing the user requirements specification to selecting the system, testing and operational release, including using electronic signatures. This logical and uniquely organised book provides the background to the regulatory requirements, interpretation of the regulations and documented evidence needed to support a claim that a system is validated. Development of the system, risk management, operation and finally system retirement and data migration are discussed. Case studies and practical examples are provided where appropriate. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements is ideal for the chromatographer working in analytical laboratories in the regulated pharmaceutical, contract research, biotechnology and medical device industries seeking the practical guidance required for validating their chromatography data systems in order to meet regulatory requirements. It will also be welcomed by consultants or those in regulatory agencies.

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Produktdetails

• Verlag: RSC
• Seitenzahl: 290
• Erscheinungstermin: 31. Oktober 2007
• Englisch
• ISBN-13: 9781847552297
• Artikelnr.: 44762588

Autorenporträt

R D McDowall, Loughborough University, UK

Inhaltsangabe

How to use this book
Introduction to Chromatography Data Systems
Regulatory Requirements for CDS Validation
Concepts of Computer Validation
CDS Validation: Managing System Risk
Process Redesign to Exploit the Tangible Benefits of Electronic Signatures with a CDS
Writing the User Requirements Specification (URS)
Controlling the Work: The Validation Plan
System Selection
Auditing the CDS Vendor
Contract, Purchase Order and Planning the Installation
Risk Assessment and Requirements Traceability
Installation Qualification and Operational Qualification (IQ and OQ)
Performance Qualification (PQ) or End User Testing
User Training and System Documentation
IT Support of the System
System Description
Validation Summary Report
Defining Electronic Records for a CDS
Maintaining the Validation Status during Operational Life
Periodic Review of the CDS
Records Retention
CDS Data Migration
CDS System Retirement
Retrospective Validation
References