Validation in Thermal Analysis.

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Schubnell, Markus
Formato: Electrónico eBook
Idioma:Inglés
Publicado: [Place of publication not identified] : Carl Hanser Verlag GmbH & Co. KG : Carl Hanser Verlag GmbH & Co. KG, 2022.
Temas:
Thermal analysis > Computer programs.
Computer programs > Validation.
Electronic books.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Intro
  • List of Contributors
  • Contents
  • Introduction
  • Part 1: Validation of Computerized Systems
  • 1 Changes in Regulations and Regulatory Guidance Since the First Mettler-Toledo Edition
  • 1.1 Data Integrity
  • 1.1.1 Regulatory Authority Data Integrity Guidance Documents
  • 1.1.2 Industry Data Integrity Guidance Documents
  • 1.1.3 ALCOA+ Criteria for Integrity of Laboratory Data
  • 1.1.4 Static and Dynamic Data
  • 1.1.5 Data Integrity Guidance Summary
  • 1.2 Updating EU Good Manufacturing Practice (GMP) Regulations
  • 1.3 USP Analytical Instrument Qualification
  • 1.4 GAMP 5 Guide and Validation of Laboratory Systems Good Practice Guide
  • 1.5 Validation of Analytical Procedures
  • 1.6 A Data Integrity Model
  • 2 Instrument Qualification, Computerized System Validation and Method Validation
  • 2.1 Terminology
  • 2.1.1 What is a Computerized System?
  • 2.1.2 Instrument Calibration and Adjustment
  • 2.1.3 Analytical Instrument Qualification (AIQ)
  • 2.1.4 Computerized System Validation (CSV)
  • 2.1.5 Reconciling Analytical Instrument Qualification and Computerized System Validation
  • 2.1.6 Different Aims of Computerized System Validation IQ and OQ
  • 2.1.7 Future of the 4Qs Model
  • 2.1.8 Analytical Method Validation (AMV)
  • 2.1.9 AIQ, CSV and AMV Interrelationships
  • 2.2 Apply Validated Methods Using Qualified Instrumentation
  • 2.3 Distinguishing between Analytical Instrument Qualification and Method Validation
  • 2.3.1 What is Done in AIQ and What is Done in AMV?
  • 2.3.2 Impact of AIQ on Method Transfer
  • 3 Regulatory Requirements for Computerized System Validation
  • 3.1 Regulatory Agencies
  • 3.2 Responsibility for Computerized System Validation
  • 3.3 Regulations and Guidelines Impacting a Computerized System
  • 3.3.1 FDA Good Manufacturing Practice (GMP) 21 CFR Part 211
  • 3.3.2 Quality System Regulation for Medical Devices: 21 CFR Part 820
  • 3.3.3 ICH Q7(R1): GMP for Active Pharmaceutical Ingredients
  • 3.3.4 Electronic Records and Electronic Signatures: 21 CFR Part 11
  • 3.3.5 European Union GMP Annex 11 for Computerized Systems
  • 3.3.6 FDA Guidance on General Principles of Software Validation
  • 3.3.7 FDA Guidance on Computerized Systems Used in Clinical Investigations
  • 3.3.8 PIC/S Guidance for Computerized Systems
  • 3.3.9 Summary of Regulatory Requirements
  • 3.4 ISO 17025: 2017
  • 3.5 Warning Letters and Observations Involving Data Integrity and Computerized System
  • 3.5.1 Quality Management System Failures
  • 3.5.2 Instrument Citations
  • 3.5.3 Citations for Lack of Laboratory Controls
  • 3.5.4 Failure to Have Complete Laboratory Records
  • 3.5.5 Key Data Integrity and CSV Inspection Learning Points
  • 4 Computerized System Validation
  • 4.1 Why Bother to Validate Your Computerized System?
  • 4.2 What is Computerized System Validation (CSV)?
  • 4.2.1 Principles of Computerized System Validation
  • 4.2.2 Computerized System Validation Assumptions and Misconceptions

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