eBook
View in EDS

Validation in Thermal Analysis

Bibliographic Details
Title: Validation in Thermal Analysis
Description: 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
Authors: Markus Schubnell
Resource Type: eBook.
Subjects: Computer programs--Validation, Thermal analysis--Computer programs
Categories: TECHNOLOGY & ENGINEERING / Materials Science / General, COMPUTERS / Reference, TECHNOLOGY & ENGINEERING / Chemical & Biochemical
Database: eBook Index
FullText Text:
  Availability: 0
Header DbId: edsebk
DbLabel: eBook Index
An: 3538497
RelevancyScore: 962
AccessLevel: 6
PubType: eBook
PubTypeId: ebook
PreciseRelevancyScore: 962.24267578125
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Validation in Thermal Analysis
– Name: Abstract
  Label: Description
  Group: Ab
  Data: 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
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AR" term="%22Markus+Schubnell%22">Markus Schubnell</searchLink>
– Name: TypePub
  Label: Resource Type
  Group: TypPub
  Data: eBook.
– Name: Subject
  Label: Subjects
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22Computer+programs--Validation%22">Computer programs--Validation</searchLink><br /><searchLink fieldCode="DE" term="%22Thermal+analysis--Computer+programs%22">Thermal analysis--Computer programs</searchLink>
– Name: SubjectBISAC
  Label: Categories
  Group: Su
  Data: <searchLink fieldCode="ZK" term="%22TECHNOLOGY+%26+ENGINEERING+%2F+Materials+Science+%2F+General%22">TECHNOLOGY & ENGINEERING / Materials Science / General</searchLink><br /><searchLink fieldCode="ZK" term="%22COMPUTERS+%2F+Reference%22">COMPUTERS / Reference</searchLink><br /><searchLink fieldCode="ZK" term="%22TECHNOLOGY+%26+ENGINEERING+%2F+Chemical+%26+Biochemical%22">TECHNOLOGY & ENGINEERING / Chemical & Biochemical</searchLink>
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edsebk&AN=3538497
RecordInfo BibRecord:
  BibEntity:
    Classifications:
      – Code: 543.260285
        Scheme: ddc
        Type: prePub
    Languages:
      – Code: eng
        Text: English
    Subjects:
      – SubjectFull: Computer programs--Validation
        Type: general
      – SubjectFull: Thermal analysis--Computer programs
        Type: general
    Titles:
      – TitleFull: Validation in Thermal Analysis
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Markus Schubnell
      – PersonEntity:
          Name:
            NameFull: Markus Schubnell
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 01
              Type: published
              Y: 2022
            – D: 15
              M: 02
              Type: profile
              Y: 2023
          Identifiers:
            – Type: isbn-print
              Value: 9781569909065
            – Type: isbn-electronic
              Value: 9781569909072
          Titles:
            – TitleFull: Validation in Thermal Analysis
              Type: main
ResultId 1