International IT regulations and compliance [[electronic resource] ] : quality standards in the pharmaceutical and regulated industries / / Siri H. Segalstad

• Record Nr.: UNINA9910144386003321
• Autore: Segalstad Siri H
• Pubbl/distr/stampa: Chichester, West Sussex, United Kingdom, : Wiley, 2008
• ISBN: 1-282-34277-0; 9786612342776; 0-470-72182-0; 0-470-72183-9
• Descrizione fisica: 1 online resource (340 p.)
• Disciplina: 615; 615.19
• Soggetti: Pharmaceutical technology - Standards; Pharmaceutical industry - Standards; Pharmaceutical industry - Quality control; Drugs - Standards; Electronic books.
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references and index.
• 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
• Sommario/riassunto: Standards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. International IT Regulations and Compliance brings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries. The book provides professionals in pharmaceutical and semiconductor industries with an updated overview of requirements for handling IT systems according to various Quality Standards and how to ?translate? these re