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Table Of Contents

1.1 Literature Overview
1.2 Terminology: Validation vs. Qualification
1.3 Components of Analytical Data Quality
Regulations and Quality Standards
2.1 Good Laboratory Practice Regulations
2.2 Current Good Manufacturing Practice Regulations
2.3 International Conference for Harmonization
2.5 ISO/IEC 17025
2.7 Learning from Regulations and Quality Standards
Qualification of Analytical Instruments
3.1 Qualification Planning
3.2 Design Qualification
Vendor Assessment
3.3 Installation Qualification
Testing for Installation Qualification
(Preventive) Maintenance and Repair
Change Control
Validation of Software and Computer Systems
4.1 Master and Project Planning
4.2 Requirement Specifications
4.3 Vendor Assessment
4.4 Installation Qualification
4.5 Operational Qualification
4.6 Performance Qualification
4.7 Configuration Management and Change Control
4.8 Validation Report
4.9 Validation of Existing/Legacy Systems
4.10 Validation of Spreadsheet Applications
Implementing USP Chapter <1058>
5.1 <1058> Instrument Groups
5.2 Allocating Instrument into Instrument Groups
Quality Assurance
Developers, Manufacturers and Vendors
Agilent Technologies’ Commitment to Compliance
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Published by: dr-statz on Oct 27, 2010
Copyright:Attribution Non-commercial


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