International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries - Hardcover

Segalstad, Siri H.

Hardcover

ISBN 10: 0470758821 ISBN 13: 9780470758823

Publisher: Wiley, 2008

Synopsis

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 requirements in the regulations.

About this title

About the Author

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.

From the Back Cover

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.

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.

Edition details

• Publisher: Wiley
• Publication date: 2008
• Language: English
• ISBN 10: 0470758821
• ISBN 13: 9780470758823
• Binding: Hardcover
• Edition number: 1
• Number of pages: 344