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00000cam a22000003i 4500 |
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SCIDIR_on1369062498 |
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OCoLC |
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20231120010725.0 |
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m o d |
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cr cnu|||unuuu |
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230207s2022 xx o 000 0 eng d |
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|a N$T
|b eng
|e rda
|e pn
|c N$T
|d EBLCP
|d YDX
|d OCLCQ
|d OCLCF
|d OCLCQ
|d OCLCO
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| 019 |
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|a 1367235030
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| 020 |
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|a 9781569909072
|q (electronic bk.)
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|a 1569909075
|q (electronic bk.)
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|z 9781569909065
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|z 1569909067
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| 035 |
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|a (OCoLC)1369062498
|z (OCoLC)1367235030
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| 050 |
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4 |
|a QD79.T38
|b S38 2022
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| 082 |
0 |
4 |
|a 543/.260285
|2 23/eng/20230213
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| 100 |
1 |
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|a Schubnell, Markus.
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| 245 |
1 |
0 |
|a Validation in Thermal Analysis.
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| 264 |
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1 |
|a [Place of publication not identified] :
|b Carl Hanser Verlag GmbH & Co. KG :
|b Carl Hanser Verlag GmbH & Co. KG,
|c 2022.
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| 300 |
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|a 1 online resource.
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| 336 |
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|a text
|b txt
|2 rdacontent
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| 337 |
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|a computer
|b c
|2 rdamedia
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| 338 |
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|a online resource
|b cr
|2 rdacarrier
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0 |
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|a Vendor-supplied metadata.
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0 |
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|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
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| 505 |
8 |
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|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
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| 505 |
8 |
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|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
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|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
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|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
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| 504 |
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|a Includes bibliographical references and index.
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| 650 |
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0 |
|a Thermal analysis
|x Computer programs.
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| 650 |
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0 |
|a Computer programs
|x Validation.
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| 650 |
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6 |
|a Logiciels
|x Validation.
|0 (CaQQLa)201-0128950
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| 650 |
|
7 |
|a Computer programs
|x Validation
|2 fast
|0 (OCoLC)fst00872447
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| 650 |
|
7 |
|a Thermal analysis
|x Computer programs
|2 fast
|0 (OCoLC)fst01149742
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| 655 |
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0 |
|a Electronic books.
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| 776 |
0 |
8 |
|c Original
|z 9781569909065
|z 1569909067
|w (OCoLC)1346519836
|
