Overview

The validation of equipment, processes and methods is a basic requirement that nowadays has to be met in most industries. This handbook deals with the validation of computerized systems in general as well as with analytical method validation. The many detailed practical examples focus on thermal analysis of materials, such as plastics and rubber. The handbook is intended for newcomers interested in the theoretical and regulatory aspects of validation and for thermal analysis practitioners who have to validate their equipment and methods.

Full Product Details

Author:   Markus Schubnell
Publisher:   Hanser Publications
Imprint:   Hanser Publications
Dimensions:   Width: 21.50cm , Height: 2.00cm , Length: 29.90cm
Weight:   0.556kg
ISBN:  

9781569909065

ISBN 10:   1569909067
Pages:   276
Publication Date:   31 August 2022
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   Available To Order  
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Table of Contents

Part 1: Validation of Computerized Systems Recent Changes in Regulations and Regulatory Guidance Instrument Qualification, Computerized System Validation and Method Validation Regulatory Requirements for Computerized System Validation Computerized System Validation Writing the User Requirements Specification (URS) Auditing the System Supplier Installation Qualification and Operational Qualification (IQ and OQ) Performance Qualification (PQ) or End User Testing Part 2: Method Validation Measurement Errors and Uncertainty of Measurement Validation of Analytical Procedures and Methods Interlaboratory Studies in Thermal Analysis Method Development Through to SOP Practical Examples Appendix 1: 21 CFR Part 11 and EU GMP Annex 11 Appendix 2: Basic Statistics Appendix 3: Standard Test Methods for Thermal Analysis

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Author Information

Dr. Markus Schubnell is a Thermal Analysis Application Specialist at Mettler-Toledo International, Inc., Switzerland. He coordinated this writing of this book with support form several colleagues in the Materials Characterization Support Group at Mettler-Toledo, and from industry and academic experts elsewhere.

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