Validation in Thermal Analysis.

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 ana...

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Bibliographic Details
Main Author: Schubnell, Markus.
Format: eBook
Language: English
Published: [Place of publication not identified] : Carl Hanser Verlag GmbH & Co. KG : Carl Hanser Verlag GmbH & Co. KG, 2022.
Subjects:
Thermal analysis > Computer programs.
Computer programs > Validation.
elektronické knihy
electronic books
ISBN: 9781569909072
1569909075
9781569909065
1569909067
Physical Description: 1 online resource.

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Table of contents

LEADER 05162cam a22004333i 4500
001 kn-on1369062498
003 OCoLC
005 20240717213016.0
006 m o d
007 cr cn|||||||||
008 230207s2022 xx o 000 0 eng d
040 |a N$T  |b eng  |e rda  |e pn  |c N$T  |d EBLCP  |d YDX  |d OCLCQ  |d OCLCF  |d OCLCQ  |d OCLCO  |d OCLCQ  |d OCLCL  |d OCLCQ  |d SFB  |d OCLCQ 
020 |a 9781569909072  |q (electronic bk.) 
020 |a 1569909075  |q (electronic bk.) 
020 |z 9781569909065 
020 |z 1569909067 
035 |a (OCoLC)1369062498  |z (OCoLC)1367235030 
100 1 |a Schubnell, Markus. 
245 1 0 |a Validation in Thermal Analysis. 
264 1 |a [Place of publication not identified] :  |b Carl Hanser Verlag GmbH & Co. KG :  |b Carl Hanser Verlag GmbH & Co. KG,  |c 2022. 
300 |a 1 online resource. 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
505 0 |a 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 
505 8 |a 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 
505 8 |a 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 
505 8 |a 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 
505 8 |a 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 
504 |a Includes bibliographical references and index. 
506 |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty 
520 |a 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. 
590 |a Knovel  |b Knovel (All titles) 
650 0 |a Thermal analysis  |x Computer programs. 
650 0 |a Computer programs  |x Validation. 
655 7 |a elektronické knihy  |7 fd186907  |2 czenas 
655 9 |a electronic books  |2 eczenas 
776 0 8 |c Original  |z 9781569909065  |z 1569909067  |w (OCoLC)1346519836 
856 4 0 |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpVTA00001/validation-in-thermal?kpromoter=marc  |y Full text 

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