Bøger af Markus Schubnell

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.Contents:Part 1: Validation of Computerized SystemsRecent Changes in Regulations and Regulatory GuidanceInstrument Qualification, Computerized System Validation and Method ValidationRegulatory Requirements for Computerized System ValidationComputerized System ValidationWriting the User Requirements Specification (URS)Auditing the System SupplierInstallation Qualification and Operational Qualification (IQ and OQ)Performance Qualification (PQ) or End User TestingPart 2: Method ValidationMeasurement Errors and Uncertainty of MeasurementValidation of Analytical Procedures and MethodsInterlaboratory Studies in Thermal AnalysisMethod Development Through to SOPPractical ExamplesAppendix 1: 21 CFR Part 11 and EU GMP Annex 11Appendix 2: Basic StatisticsAppendix 3: Standard Test Methods for Thermal Analysis