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Record Nr. |
UNINA9910877343903321 |
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Autore |
Segalstad Siri H |
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Titolo |
International IT regulations and compliance : quality standards in the pharmaceutical and regulated industries / / Siri H. Segalstad |
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Pubbl/distr/stampa |
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Chichester, West Sussex, United Kingdom, : Wiley, 2008 |
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ISBN |
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1-282-34277-0 |
9786612342776 |
0-470-72182-0 |
0-470-72183-9 |
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Descrizione fisica |
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1 online resource (340 p.) |
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Disciplina |
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Soggetti |
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Pharmaceutical technology - Standards |
Pharmaceutical industry - Standards |
Pharmaceutical industry - Quality control |
Drugs - Standards |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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International IT Regulations and Compliance; Contents; Preface and Acknowledgements; 1 Quality Standards; 1.1 What Quality Is; 1.2 Mandatory and Voluntary Standards; 1.3 Pharmaceutical Industry Regulations; 1.4 US GxP Regulations; 1.5 European GxP Regulations; 1.6 Other GxP Regulations; 1.7 Good Manufacturing Practice; 1.8 Good Laboratory Practice; 1.9 Good Clinical Practice; 1.10 Medical Device Standards; 1.11 IT Systems in the GxP and Medical Device Regulations; 1.12 GAMP; 1.13 Mandatory Quality Standards in Other Industries; 1.14 Legal Issues; 1.15 The ISO; 1.16 The ASTM; 1.17 The IEEE |
1.18 TasksReferences; 2 Regulatory Requirements for IT Systems; 2.1 Introduction; 2.2 US Requirements; 2.3 EU Requirements; 2.4 21 CFR Part 11; 2.5 The 'Part 11 Project'; 2.6 EU GMP Annex 11; 2.7 The PIC Document PI 011 Recommendation on Computerized Systems in Regulated 'GxP' Environments; 2.8 GAMP; 2.9 The ISO 9000 Series; 2.10 A Comparison between the Standards; 2.11 Conclusion; 2.12 Tasks; References; 3 IT Security; 3.1 Introduction; 3.2 Continuous Connections - Wireless Networks; 3.3 Threats; 3.4 The Security Policy; 3.5 Tasks; |
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