Siri H. Segalstad

International IT Regulations and Compliance (eBook, PDF)

Quality Standards in the Pharmaceutical and Regulated Industries

• Format: PDF

Produktbeschreibung

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.

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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 338
• Erscheinungstermin: 20. November 2008
• Englisch
• ISBN-13: 9780470721834
• Artikelnr.: 37298791

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)