Design And Implementation Of Large Infusion Manufacture Execution System

Large infusion is an intravenous drug.The quality control requirements for large infusion are very strict.In order to obtain high quality large infusion drug,the control of large infusion production process must be realized.In 2011,China Food and Drug Administration issued a new version of Good Manufacturing Practice.The new version makes mandatory requirements for drug production process quality control in pharmaceutical companies.But the current domestic pharmaceutical companies manage drug production process mainly by resource management systems such as ERP,MRP and equipment control systems such as DCS,SCADA.The quality control of drug production process lacks effective ways and cannot meet the requirements of Good Manufacturing Practice.In order to achieve quality control of drug production process which met the requirements of Good Manufacturing Practice,combined with the actual needs of a pharmaceutical factory on large infusion production process quality control,a large infusion Manufacture Execution System software was presented to design and develop.The software could resolve the loss problem of large infusion production process information and provide a rich data basis for batch quality control and finally achieve a complete quality control of large infusion production process.Based on the analysis of large infusion production business flow and system requirements,the large infusion Manufacture Execution System overall framework was designed and the system software development framework which mixed Struts with Spring based on J2 EE platform was presented and set up.And according to the developing specifications,a large infusion Manufacture Execution System was realized.In the process of developing the large infusion Manufacture Execution System,in order to reduce the risk of software development and obtain a high quality software product,a method based on an improved Microsoft Process Model was proposed to develop the large infusion Manufacture Execution System software.This method improved the response speed to uncertain factors and realized quickly and efficiently developing of high quality software under the constraint of limited resources and limited development time.In order to improve the disaster recovery capacity of the system,guarantee the system database integrity and business operations uninterrupted when a disaster occurred,the Online Dual Backup technology was used to get a real-time and remote backup of the system local database.The load balancing technology was used to construct the application server cluster.These technologies improved the system’s availability effectively and enhanced the system’s ability to provide services continually.In order to resolve the problem of data sharing conflicts caused by multi-user concurrent operation,a strategy for implementing data access control based on version number was presented.When testing the system’s functions,in order to improve test efficiency and test quality,an automatic test cases generation method based on Directed Sequence Graph was presented.The test application result in large infusion Manufacture Execution System showed that this method could generate test cases effectively and had high test efficiency and test coverage.The large infusion Manufacture Execution System developed here was tested in many ways under laboratory conditions.The test result showed that this system met the design requirements,had a stable performance and correct functions and achieved a complete quality control of large infusion production process.