The Research Of The GMP Control System In A Pharmaceutical Integrated Environment Of PDM & ERP

The hot research about integrated technology, which included three different grades on function level, process level and enterprise level, is directly brought on by the status of isolated information area in the different software modules of CIMS in the manufacturing industry. As the main parts of CIMS, the software system of PDM and ERP will face the integrated trend consequentially. As the common key modules of PDM and ERP, the BOM and the Routing mode are offered to produce a natural act of combination for integrating PDM and ERP systems. On the basis of this circus, both the method of integrating data in PDM system and the mode of control process in ERP system are described in detail in this paper. Then the author tries to expatiating the importance and advantages of the combination between PDM and ERP by colluding the clue of BOM and Routing. Especially, through discussing the particular mode of integrating PDM and ERP, a new model of integrating management project in manufacturing enterprise and BOM is chiefly put to act the core function of the new integrating model. Strict control with GMP in manufacturing cycle is one of the most distinct characteristics of the Pharmaceutical enterprise, which is a main form of manufacturing. So on the basis of having discussed the basic theories and the software structure of GMP, the paper specially expatiates the PDM management model, the ERP control model and the GMP criterion model, and constitutes a new GMP model of integrating PDM and ERP in the Pharmaceutical enterprise by combine the data and process consistency of PDM, ERP and GMP. Along with the important core station on the integrating model are assigned to the Routing management, the thesis chiefly completes the demand analysis, Systems analysis and process analysis of the model system. Then the author analyses and designs the Conceptual and Physical data model of the software system. On the other hand, along with the evolution of UML and OO tools, this thesis analyses and researches the use-case and interaction diagram of the Integrated model by the tool of Rational Rose 2003.The Integrated model system is finally implemented with PowerBuilder 8.0 and Sybase 11.5. and procures the expected effects by being applied in a large-scale pharmaceutical enterprise smoothly.