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International IT regulations and compliance [[electronic resource] ] : quality standards in the pharmaceutical and regulated industries / / Siri H. Segalstad
International IT regulations and compliance [[electronic resource] ] : quality standards in the pharmaceutical and regulated industries / / Siri H. Segalstad
Autore Segalstad Siri H
Pubbl/distr/stampa Chichester, West Sussex, United Kingdom, : Wiley, 2008
Descrizione fisica 1 online resource (340 p.)
Disciplina 615
615.19
Soggetto topico Pharmaceutical technology - Standards
Pharmaceutical industry - Standards
Pharmaceutical industry - Quality control
Drugs - Standards
Soggetto genere / forma Electronic books.
ISBN 1-282-34277-0
9786612342776
0-470-72182-0
0-470-72183-9
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto 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; References; 4 Quality Management Systems
4.1 An Introduction to QMS4.2 Definitions; 4.3 Principles for Quality Management; 4.4 Quality Management System Levels; 4.5 Creating a QMS; 4.6 Roles and Responsibilities; 4.7 Work Processes; 4.8 Controlled Documents; 4.9 The Quality Policy; 4.10 The Quality Manual; 4.11 Standard Operating Procedures; 4.12 The Art of Writing an SOP; 4.13 Tasks; References; 5 IT Integrated in the QMS in the User Organization; 5.1 Introduction; 5.2 How to Integrate IT Systems in the QMS; 5.3 Generic Standard Operating Procedures; 5.4 Procedures for Each System; 5.5 Tasks; References
6 IT Integrated in the Supplier's QMS6.1 Introduction; 6.2 Which Standards Should Be Used?; 6.3 The Quality Management System; 6.4 System Development Models; 6.5 Documents for Software Development; 6.6 The Customer-Supplier Relationship; 6.7 Tasks; References; 7 Organization for an IT System; 7.1 Introduction; 7.2 Roles and Responsibilities for a Live System; 7.3 Groups in the IT System Organization; 7.4 Roles and Responsibilities for an IT Validation Project; 7.5 Outsourcing; 7.6 The Service Level Agreement for Outsourcing; 7.7 Consultants; References
8 The Legal Implications of an IT System8.1 Introduction; 8.2 Pharmaceutical Regulations; 8.3 Financial Systems; 8.4 Patent Systems; 8.5 Human Resources Systems; 8.6 Healthcare Systems; 8.7 Systems for Legal Information; Reference; 9 Advanced Quality Management Systems; 9.1 Introduction; 9.2 The Live QMS is a Good QMS; 9.3 Changes; 9.4 How to Keep the QMS Updated; 9.5 Training and Understanding; 9.6 How to use a QMS Effectively as a Tool in the Organization - Not as a Straightjacket; 9.7 Tasks; References; 10 Audits; 10.1 Introduction; 10.2 The ISO 9000 Series; 10.3 TickIT; 10.4 Why Audit?
10.5 Audit in a Risk-Based Environment
Record Nr. UNINA-9910144386003321
Segalstad Siri H  
Chichester, West Sussex, United Kingdom, : Wiley, 2008
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
International IT regulations and compliance [[electronic resource] ] : quality standards in the pharmaceutical and regulated industries / / Siri H. Segalstad
International IT regulations and compliance [[electronic resource] ] : quality standards in the pharmaceutical and regulated industries / / Siri H. Segalstad
Autore Segalstad Siri H
Pubbl/distr/stampa Chichester, West Sussex, United Kingdom, : Wiley, 2008
Descrizione fisica 1 online resource (340 p.)
Disciplina 615
615.19
Soggetto topico Pharmaceutical technology - Standards
Pharmaceutical industry - Standards
Pharmaceutical industry - Quality control
Drugs - Standards
ISBN 1-282-34277-0
9786612342776
0-470-72182-0
0-470-72183-9
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto 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; References; 4 Quality Management Systems
4.1 An Introduction to QMS4.2 Definitions; 4.3 Principles for Quality Management; 4.4 Quality Management System Levels; 4.5 Creating a QMS; 4.6 Roles and Responsibilities; 4.7 Work Processes; 4.8 Controlled Documents; 4.9 The Quality Policy; 4.10 The Quality Manual; 4.11 Standard Operating Procedures; 4.12 The Art of Writing an SOP; 4.13 Tasks; References; 5 IT Integrated in the QMS in the User Organization; 5.1 Introduction; 5.2 How to Integrate IT Systems in the QMS; 5.3 Generic Standard Operating Procedures; 5.4 Procedures for Each System; 5.5 Tasks; References
6 IT Integrated in the Supplier's QMS6.1 Introduction; 6.2 Which Standards Should Be Used?; 6.3 The Quality Management System; 6.4 System Development Models; 6.5 Documents for Software Development; 6.6 The Customer-Supplier Relationship; 6.7 Tasks; References; 7 Organization for an IT System; 7.1 Introduction; 7.2 Roles and Responsibilities for a Live System; 7.3 Groups in the IT System Organization; 7.4 Roles and Responsibilities for an IT Validation Project; 7.5 Outsourcing; 7.6 The Service Level Agreement for Outsourcing; 7.7 Consultants; References
8 The Legal Implications of an IT System8.1 Introduction; 8.2 Pharmaceutical Regulations; 8.3 Financial Systems; 8.4 Patent Systems; 8.5 Human Resources Systems; 8.6 Healthcare Systems; 8.7 Systems for Legal Information; Reference; 9 Advanced Quality Management Systems; 9.1 Introduction; 9.2 The Live QMS is a Good QMS; 9.3 Changes; 9.4 How to Keep the QMS Updated; 9.5 Training and Understanding; 9.6 How to use a QMS Effectively as a Tool in the Organization - Not as a Straightjacket; 9.7 Tasks; References; 10 Audits; 10.1 Introduction; 10.2 The ISO 9000 Series; 10.3 TickIT; 10.4 Why Audit?
10.5 Audit in a Risk-Based Environment
Record Nr. UNINA-9910830674403321
Segalstad Siri H  
Chichester, West Sussex, United Kingdom, : Wiley, 2008
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
International IT regulations and compliance : quality standards in the pharmaceutical and regulated industries / / Siri H. Segalstad
International IT regulations and compliance : quality standards in the pharmaceutical and regulated industries / / Siri H. Segalstad
Autore Segalstad Siri H
Pubbl/distr/stampa Chichester, West Sussex, United Kingdom, : Wiley, 2008
Descrizione fisica 1 online resource (340 p.)
Disciplina 615/.19
Soggetto topico Pharmaceutical technology - Standards
Pharmaceutical industry - Standards
Pharmaceutical industry - Quality control
Drugs - Standards
ISBN 1-282-34277-0
9786612342776
0-470-72182-0
0-470-72183-9
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto 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; References; 4 Quality Management Systems
4.1 An Introduction to QMS4.2 Definitions; 4.3 Principles for Quality Management; 4.4 Quality Management System Levels; 4.5 Creating a QMS; 4.6 Roles and Responsibilities; 4.7 Work Processes; 4.8 Controlled Documents; 4.9 The Quality Policy; 4.10 The Quality Manual; 4.11 Standard Operating Procedures; 4.12 The Art of Writing an SOP; 4.13 Tasks; References; 5 IT Integrated in the QMS in the User Organization; 5.1 Introduction; 5.2 How to Integrate IT Systems in the QMS; 5.3 Generic Standard Operating Procedures; 5.4 Procedures for Each System; 5.5 Tasks; References
6 IT Integrated in the Supplier's QMS6.1 Introduction; 6.2 Which Standards Should Be Used?; 6.3 The Quality Management System; 6.4 System Development Models; 6.5 Documents for Software Development; 6.6 The Customer-Supplier Relationship; 6.7 Tasks; References; 7 Organization for an IT System; 7.1 Introduction; 7.2 Roles and Responsibilities for a Live System; 7.3 Groups in the IT System Organization; 7.4 Roles and Responsibilities for an IT Validation Project; 7.5 Outsourcing; 7.6 The Service Level Agreement for Outsourcing; 7.7 Consultants; References
8 The Legal Implications of an IT System8.1 Introduction; 8.2 Pharmaceutical Regulations; 8.3 Financial Systems; 8.4 Patent Systems; 8.5 Human Resources Systems; 8.6 Healthcare Systems; 8.7 Systems for Legal Information; Reference; 9 Advanced Quality Management Systems; 9.1 Introduction; 9.2 The Live QMS is a Good QMS; 9.3 Changes; 9.4 How to Keep the QMS Updated; 9.5 Training and Understanding; 9.6 How to use a QMS Effectively as a Tool in the Organization - Not as a Straightjacket; 9.7 Tasks; References; 10 Audits; 10.1 Introduction; 10.2 The ISO 9000 Series; 10.3 TickIT; 10.4 Why Audit?
10.5 Audit in a Risk-Based Environment
Record Nr. UNINA-9910877343903321
Segalstad Siri H  
Chichester, West Sussex, United Kingdom, : Wiley, 2008
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui