ABSTRACT
Computer systems support billions of dollars of pharmaceutical and healthcare sales revenues. The pharmaceutical and healthcare industry has increasingly used computers to support the development and manufacturing of their products. Within research environments, computer systems are used to speed up product development, reducing the time between the registration of a patent and product approval and, hence, optimizing the time available to manufacture a product under a patent. Computer systems are also used to support routine supply of medicinal products to improve manufacturing performance, reduce production costs, and improve product quality. It is important that these systems are fit for purpose from a business and regulatory perspective. Regulatory authorities treat a lack of regulatory computer system compliance as a serious GxP deviation. Pharmaceutical and healthcare companies need a balanced, proactive, and coordinated strategy that addresses short-, medium-, and long-term and internal and external needs and priorities. This book aims to provide practical advice and guidance on how to do this on the basis of extensive industry experience and with reference to the latest regulatory developments and industry trends.
