Quality analytics measures increasingly are being recognized by global health authorities as a necessary mechanism for monitoring compliance across regulated companies. The United States Food & Drug Administration (FDA) is pursuing standards of quality metrics to create a more flexible and rationalized review and continuous inspection system. Use of these metrics will facilitate the agency’s intended transition from an inspection mode to proactive surveillance under a risk-based approach.
Industry groups are working proactively with the FDA to develop best practices for identifying and reporting key quality metrics, evaluation criteria, and managing related electronic submissions. A well-developed and transparent system promises to add value in terms of greater understanding and control of internal processes, as well as by reducing the need for traditional inspections and providing for a streamlined review of supplemental filings.
Successful companies invest in analytical capabilities to support the following business drivers: launch of new products, introduction of new facilities, processes improvements, technology monitoring, growth of the supply chain, expanding markets, complexity of specialty business models, internal manufacturing and external supplier/partner integration.
CGI's quality analytics solution
CGI takes an integrated approach to quality analytics that includes industry best practices, FDA priorities and critical metrics, and CGI’s target state POV that delivers an analysis set of capabilities, business design and a robust analytics foundation.
We have worked with major life science partners to design and develop innovative quality-based analytics solutions. Our success stories include the full life cycle of implementation. From establishing organizational priorities to delivering full road maps, design and capability integration, we help our clients better analyze what they manage.