Producers versus regulators? an enquiry into pharmaceutical quality information systems

Given rising costs and declining R&D productivity, the pharmaceutical industry needs information systems and processes that contribute to business efficiency and cost reduction without compromising fundamental quality and safety principles. This study investigated quality information systems in the pharmaceutical industry and the relationship between the industry and its regulators. The data demonstrated a risk-based approach to information management and a quality-by-design philosophy in the industry, aiming to satisfy the needs of product regulators, optimise manufacturing process efficiencies, and give patients reliably consistent medicines and devices. The data also revealed a problematic perception of regulatory oversight, with highly significant correlations between level of regulator contact and ‘difficulty’ with regulators (r=0.92) and between difficulty with regulators and delays in IT implementations (r=0.87).We propose that emerging trends in standards-based interoperability offer a new paradigm for the industry and its regulators.