Quality Standards in the Pharmaceutical and Regulated Industries
This book aims to bring together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries. It will allow the reader 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 the organization and to assess QMS from other companies during a vendor audit. In addition, it presents details of what the laboratory systems are and what they do in order to understand how they can be validated. It is not an objective to understand the chemistry and theory behind these instrument systems. Finally, it 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.
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.
