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

Front Cover
John Wiley & Sons, Nov 20, 2008 - Law - 338 pages
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.
 

What people are saying - Write a review

User Review - Flag as inappropriate

zz

Contents

1 Quality Standards
1
2 Regulatory Requirements for IT Systems
19
3 IT Security
51
4 Quality Management Systems
57
5 IT Integrated in the QMS in the User Organization
75
6 IT Integrated in the Suppliers QMS
99
7 Organization for an IT System
119
8 The Legal Implications of an IT System
127
13 Development Qualification
189
14 Installation Qualification
205
15 Operational Qualification
209
16 ProcessPerformance Qualification
215
17 Laboratory Instrument Systems
225
18 Laboratory Information Management Systems
237
19 Building Management Systems and Heating Ventilation and Air Conditioning
273
Appendix 1 Regulation comparisons
289

9 Advanced Quality Management Systems
133
10 Audits
141
11 Validation of IT Systems
157
12 Risk Assessment and Risk Management
179
Appendix 2 Terminology
295
Index
315
Copyright

Other editions - View all

Common terms and phrases

About the author (2008)

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.

Bibliographic information