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Informationen zum Autor Siri Segalstad has worked with quality and validation of IT systems since 1988 in and with the pharmaceutical industry. She set-up her own consulting company, Segalstad Consulting AS, covering these issues in 1995, and has hands-on experience with major companies in the US and in 10 countries in Europe, including Alpharma, AstraZeneca, Bayer, GE Health, Lundbeck, Nycomed, Pharmacia & Upjohn, Statoil, and various accredited laboratories. She has published more than 20 papers and given presentations and taught classes on validation from Hong Kong, Singapore, Taiwan, and Dubai in the East to California in the West. She has been on the board of the GAMP (Good Automated Manufacturing Practice) Nordic Steering Committee since its inauguration in 2001, and has participated in preparing standards in ASTM and GAMP. Klappentext After taking part in an EU Leonardo da Vinci project to create a complete curriculum for a Master's degree in IT Validation, Siri H. Segalstad decided to write this book as she realised there was a need for a comprehensive book that rings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries.This text allows the readers to acquire not only knowledge but also understanding of quality thinking and to apply this knowledge. It will allow them to use the Quality Management System (QMS) as a tool for further development in their organization and to assess QMS from other companies during a supplier audit.This book will enable the user to understand the process of validation,how to divide validation into manageable pieces, and what is included in the validation for different types of systems.Topics covered include:* Quality standards* Regulatory requirements for IT systems* Quality Management Systems-QMS* Organization for an IT system* Legal implications of an IT system* Advanced quality management systems* Validation process and validation techniques* Validation of IT systems* Risk assessment and risk management* Laboratory Information Management Systems (LIMS) and Building Management Systems (BMS)This comprehensive text will be useful to those working with quality assurance and validation of IT systems and in regulated industries, regardless of which standards they are using. Zusammenfassung 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. Inhaltsverzeichnis 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 - GMP. 1.8 Good Laboratory Practice - GLP. 1.9 Good Clinical Practice - GCP. 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 ISO. 1.16 ASTM. 1.17 IEEE. 1.18 TASKS. 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 PIC Document PI 011 Recommendation on Computerised Systems In Regulated "GXP" Environments. 2.8 GAMP. 2.9 ISO 9000-Series. 2.10 Comparison Between the Standards. 2.11 Conclusion. 2.12 Tasks. 3. IT Security. 3.1 Introduction. 3.2 Continuous Connections - Wireless Networks. 3.3 Threats. 3.4 Security Policy. 3.5 Tasks. 4. Quality Manageme...
