ABSTRACT
Computer systems support billions of dollars of pharmaceutical and healthcare sales revenues. Over the past 30 years, the pharmaceutical and healthcare industries have 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 within the production environment to improve manufacturing performance, reduce production costs, and improve product quality. It is important that these systems are validated as fit for purpose from a business and regulatory perspective. Regulatory authorities treat lack of validation as a serious deviation. Pharmaceutical and healthcare companies need a balanced, proactive, and coordinated strategy that addresses short, medium, long-term, internal, and external needs and priorities.
