Textbook

International IT Regulations and Compliance

sllide1

344 pages, ISBN 978-0-470-75882-3, Wiley-Blackwell, October 2008.
Siri H. Segalstad:
International IT Regulations and Compliance
Quality Standards in the Pharmaceutical and Regulated Industries

Publisher: John Wiley & Sons, Inc.
Cover art: Josh Hunter

Read a book review from PharmTech.com (PDF).

Table of contents:

1 QUALITY STANDARDS
2 REGULATORY REQUIREMENTS FOR IT SYSTEMS
3 IT SECURITY
4 QUALITY MANAGEMENT SYSTEMS-QMS
5 IT INTEGRATED IN THE QMS IS THE USER ORGANIZATION
6 IT INTEGRATED IN THE SUPPLIER’S QMS
7 ORGANIZATION FOR AN IT SYSTEM
8 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 OPERATION QUALIFICATION
16 PERFORMANCE / PROCESS QUALIFICATION
17 LABORATORY INSTRUMENT SYSTEMS
18 LABORATORY INFORMATION MANAGEMENT SYSTEMS (LIMS)
19 BUILDING MANAGEMENT SYSTEM (BMS) AND HEATING, VENTILATION, AIR CONDITIONING (HVAC)