Toward data compliance in vaccine industry: Interoperability to align business and information systems

The ultimate goal in the vaccine industry is product quality. However this quality can be altered by the use of a number of heterogeneous information systems with different business structures and concepts along the lifecycle of the product. Interoperability concepts may help to guarantee a certain correspondence and compliance between different product data. In this paper we focus on a particular compliance problem, between production technical data, represented in an ERP, and the corresponding regulatory directives and specifications, represented by the Marketing Authorizations (MA). The MA details the process for vaccine manufacturing according to the requirements imposed by health organizations such as Food and Drug Administration (FDA) and Committee for Medicinal Products for Human use (CHMP). The proposed approach uses an interoperability framework which is based on a multi-layer separation between the organizational aspects, business contexts, and information technologies for each involved entity into the communication between the used systems.