Output details

An ontological framework for automated regulatory compliance in pharmaceutical manufacturing

A novel approach (and a prototype software system) to facilitate the maintenance of regulatory compliance for a pharmaceutical process is proposed. The framework maintains linked representations of regulations, validation procedures and the pharmaceutical process. The approach has the potential to be applied to other tightly regulated sectors, e.g food, nuclear, financial, and is the basis of a current extension using Natural Language techniques. The paper was the result of a collaboration with the NSF-funded C-SOPS Engineering Research Center at Purdue University, USA (contact: Prof. Venkat Venkatasubramanian).