New: Book to be published in October 2008 by

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)