Process Analytical Technology, or PAT, is the name being used by the FDA to define its state-of-the-art manufacturing initiative directed toward the pharmaceutical/life sciences industry. The government's push for modern manufacturing is being inspired by antiquated processes causing substantial waste in the form of rejected batches, rework and lengthy investigations that inflate production costs by as much as 15%. Experts agree the pharmaceutical industry is far behind other industries in manufacturing technology and process reliability, and needs immediate reform for the sake of consumers and its own operating success. The FDA launched its PAT initiative in August 2002, urging "state-of-the-art technological advances in drug development, production and quality assurance." To clarify its intentions, in August 2003, the agency explained, "the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner." Tunnell Consulting has created an innovative, integrated PAT framework that fully responds to regulators' demands, that has shown superior results, and that gives firms a self-sustaining mechanism to monitor and improve ongoing manufacturing performance.