"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

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.

ISO 9001 is known throughout the world as the gold standard for quality management and process improvement, but lately quality assurance professionals are discovering the power of CMMISM ? the latest process improvement model from the Software Engineering Institute. This book explores how your organization can use these two frameworks in tandem to improve process quality by quantum leaps.

The book presents a comprehensive discussion on software quality issues and software quality assurance (SQA) principles and practices, and lays special emphasis on implementing and managing SQA. Primarily designed to serve three audiences; universities and college students, vocational training participants, and software engineers and software development managers, the book may be applicable to all personnel engaged in a software projects Features: A broad view of SQA. The book delves into SQA issues, going beyond the classic boundaries of custom-made software development to also cover in-house software development, subcontractors, and readymade software. An up-to-date wide-range coverage of SQA and SQA related topics. Providing comprehensive coverage on multifarious SQA subjects, including topics, hardly explored till in SQA texts. A systematic presentation of the SQA function and its tasks: establishing the SQA processes, planning, coordinating, follow-up, review and evaluation of SQA processes. Focus on SQA implementation issues. Specialized chapter sections, examples, implementation tips, and topics for discussion. Pedagogical support: Each chapter includes a real-life mini case study, examples, a summary, selected bibliography, review questions and topics for discussion. The book is also supported by an Instructor’s Guide.

This book provides an inexpensive and comprehensive approach to ISO 9001 registration. The book is for executives, quality managers, and project leaders of small and medium-sized software development organizations. The book assists executives, quality managers and project leaders to: reduce the time to register their companies' quality management systems and engineering processes to ISO 9001 · identify and prioritize the activities required to plan, execute, and complete the registration process · assess the costs of registration · make the interactions with consultants and registrars more productive · increase the likelihood of success the first time the company attempts ISO 9001 registration.

Dr.M.Kameswari, Associate Professor & Head, School of Advanced Sciences, Department of Mathematics, Kalasalingam Academy of Research and Education, Krishnankoil, Srivilliputhur, Tamil Nadu, India. Dr.P.Getchial Pon Packiavathi, Assistant Professor, Department of Mathematics, V.V.Vanniaperumal College for Women, Virudhunagar, Tamil Nadu, India. Dr. N.Deena, Assistant Professor, Department of Mathematics, Saraswathi Narayanan College, Perungudi, Madurai, Tamil Nadu, India. Dr.R.Srinivasan, Associate Professor, Department of Computer Science, SLS MAVMM Ayira Vaisyar College, Madurai, Tamil Nadu, India. Dr.G.Stephen, Assistant Librarian, St. Xavier's University, Kolkata, West Bengal, India.