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Beschreibung
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.
Aus dem Inhalt
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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Artikelnummern
Diesem Produkt sind folgende ISBN bzw. Artikelnummern zugeordnet:
| ISBN-13: |
978-1-56990-906-5 978-1569909065 |
|---|---|
| EAN-13: | 9781569909065 |
