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

After taking part in an EU Leonardo da Vinci project to create a complete curriculum for a Master's degree in IT Validation, Siri H. Segalstad decided to write this book as she realised there was a need for a comprehensive book that rings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries.

This text allows the readers to acquire not only knowledge but also understanding of quality thinking and to apply this knowledge. It will allow them to use the Quality Management System (QMS) as a tool for further development in their organization and to assess QMS from other companies during a supplier audit.

This book will enable the user to understand the process of validation,how to divide validation into manageable pieces, and what is included in the validation for different types of systems.

Topics covered include:

• Quality standards
• Regulatory requirements for IT systems
• Quality Management Systems-QMS
• Organization for an IT system
• Legal implications of an IT system
• Advanced quality management systems
• Validation process and validation techniques
• Validation of IT systems
• Risk assessment and risk management
• Laboratory Information Management Systems (LIMS) and Building Management Systems (BMS)

This comprehensive text will be useful to those working with quality assurance and validation of IT systems and in regulated industries, regardless of which standards they are using.