Authors:
Néjib Moalla
1
;
Abdelaziz Bouras
2
;
Gilles Neubert
2
;
Yacine Ouzrout
2
and
Nicolas Tricca
3
Affiliations:
1
CERRAL/PRISMa, IUT Lumière Lyon 2; Sanofi Pasteur, France
;
2
CERRAL/PRISMa, IUT Lumière Lyon 2, France
;
3
Sanofi Pasteur, France
Keyword(s):
Pharmaceutical Sector, Information Systems, ERP, Marketing Authorizations, Compliance, Interoperability.
Related
Ontology
Subjects/Areas/Topics:
Coupling and Integrating Heterogeneous Data Sources
;
Databases and Information Systems Integration
;
Enterprise Information Systems
;
Enterprise Resource Planning
;
Enterprise Software Technologies
;
Information Systems Analysis and Specification
;
Modeling Concepts and Information Integration Tools
;
Organisational Issues on Systems Integration
;
Simulation and Modeling
;
Simulation Tools and Platforms
;
Software Engineering
Abstract:
The ultimate goal in the pharmaceutical sector 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 is then needed 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 manufacturing the medicine according to the requirements imposed by health organisations 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 organisational aspects, business trades, and information technologie
s for each involved entity into the communication between the used systems.
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