Short description 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.
From the contents 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.
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.