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

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. quality management systems, validation plan, user requirements specification, installation qualification, operational qualification, performance qualification, quality risk management, quality policy, waterfall model, quality terminology, independent monitoring system, active pharmaceutical ingredients, system development life cycle, calibration management, covering computerized systems, compliant electronic records, laboratory computerized systems, numeric specifications, validation master plan, supplier audit, sterile facilities, traceability matrix, dissolution testing, cleanest room, validation project