Siri H. Segalstad

International IT Regulations C

• Gebundenes Buch

Produktbeschreibung

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.

Produktdetails

• Verlag: Wiley & Sons
• Artikelnr. des Verlages: 14575882000
• 1. Auflage
• Seitenzahl: 338
• Erscheinungstermin: 3. Dezember 2008
• Englisch
• Abmessung: 250mm x 175mm x 23mm
• Gewicht: 720g
• ISBN-13: 9780470758823
• ISBN-10: 0470758821
• Artikelnr.: 24923766

Autorenporträt

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.

Inhaltsangabe

Preface and Acknowledgements. 1. Quality Standards. 2. Regulatory
Requirements for IT Systems. 3. IT Security. 4. Quality Management Systems.
5. IT Integrated In the QMS in a User Organization. 6. IT Integrated in the
Supplier's QMS. 7. Organization for an IT System. 8. The Legal Implications
of an IT System. 9. Advanced Quality Management Systems. 10. Audits. 11.
Validation of IT Systems. 12. Risk Assessment and Risk Management. 13.
Development Qualification. 14. Installation Qualification. 15. Operational
Qualification. 16. Process/Performance Qualification. 17. Laboratory
Instrument Systems. 18. Laboratory Information Management Systems. 19.
Building Management System (BMS) and Heating, Ventilation, Air
Conditioning. Appendix 1 Regulation comparisons. Appendix 2 Terminology.
Index.

Rezensionen

"This book is a good reference for everyone dealing with IT systems in a regulated environment. The style and content are targeted to entry- and middle-level professionals. The author provides readers with a broad picture and strong overall understanding of IT systems." ( Pharmaceutical Technology , June 2009)