1 ) A method of integrating a computer product with a pharmaceutical manufacturing hardware system said method comprising, a) contacting the computer product to a hardware device used in pharmaceutical manufacture; b) monitoring data generated by the hardware device during pharmaceutical manufacture; c) maintaining the data over time to provide a historical record; d) analyzing the historical record to provide a risk-based assessment in case of failure; e) taking corrective action to obviate the failure whereby said corrective action comprises stopping or modifying said pharmaceutical manufacture.