Overview
The world is changing very rapidly as one economy. Industries around the world cannot avoid the ongoing globalization, and it is the same for the pharmaceutical industry. Especially, with tighter regulation and higher drug prices, domestic pharmaceutical companies are facing a difficult time and for these companies, globalization is the major assignment to overcome these troubles. To globalize domestic pharmaceutical companies, product differentiation and securing the original drugs are important, but beside this it is necessary to be equipped with the highly maximized system that meets the international standards. Advancement of production systems includes production facility extension, production process equipment, and production work staff education, but, what first of all the fact that matters is the change of information systems. It is essential to adopt the system such as Manufacturing Execution System (MES) that covers the part that previous system ERP could not, and WMS, and LIMS which interlocks with MES. MES changes the production environment in a very short time and it also provides a standardized management system. Thus, a top priority for domestic pharmaceutical companies to change information systems is to drive the MES adoption.
 
 
Strengthen your manufacturing competitive power with MES
To strengthen the manufacturing competitiveness within the pharmaceutical industry, MES delivers many benefits such as law compliance of GMP, Validation, Part 11 etc., production efficiency improvement, optimization of process operations, quality improvement, support to optimize production activities, meet delivery deadlines, etc.
 
Considerations when implementing MES
It is necessary to consider certain issues when implementing MES in the Pharmaceutical industry.

1. Smooth interface with Legacy system must be assured considering that the MES system manages various information in the production floor.
2. By applying 21 CFR Part 11 (Electronic documentation & Rules for electronic signature) & cGMP regulations, the US based FDA requires Software Validation. When implementing the MES system, the Validation must be part of this system implementation, and it necessary to check if the implementation can be done according to the Validation conditions.

3. Electronic signatures must be provided to corresponded with 21CFR Part 11 and to make clear the roles & responsibility within the production management in case of any abnormal situations. When using electronic signatures check again the user’s name and password. The signer’s name, date & time and the reason for signature must be clearly stated on the display.

4. In the pharmaceutical industry the production work is executed based on manufacturing records providing all related documents starting from production orders to shipment approval. The MES system manages all manufacturing process related information in form of electronic data.
 
 
Solution
Miracom’s manufacturing operation management solution, based on its high-class expertise and technology, is not only approved by domestic, but also by overseas customers. Furthermore, Miracom helps to successfully implement pharmaceutical information systems based on well-experienced consultants, knowledge transfer & advanced Validation technology.

 
Miracom products for pharmaceutical industry
∙ MESplus (Manufacturing Execution System)
∙ MESplus FMB (Line Monitoring System)
∙ APSplus (Advanced Planning & Scheduling)
∙ DACrux (Quality Management System)
∙ EAMplus (Enterprise Asset Management)
∙ Highway101 (Enterprise Application Integration)
 
Pointed Monitoring
- High Visibility Production Pointed Monitoring Function
- advanced problem prediction & exact assignment and report of Trouble Point
 
Miracom products for Automotive / Heavy machinery / Steel industry
∙ MESplus (Manufacturing Execution System)
∙ MESplus FMB (Line Monitoring System)
∙ APSplus (Advanced Planning & Scheduling)
∙ DACrux (Quality Management System)
∙ EAMplus (Enterprise Asset Management)
∙ Highway101 (Enterprise Application Integration)
 
 

Due to the increasing interest in health, the tobacco industry is currently confronted with various consumer requests. However, the size of the tobacco industry is continuously reducing and foreign tobacco companies are making inroad into the domestic companies which causes great challenge to domestic tobacco companies at present. To overcome these challenges, different brands must be produced, higher tobacco quality provided, and export to overseas markets considered. In addition, cutting down production costs and realizing a more flexible production process plays also an important role to stay competitive.

Miracom is the only domestic company with project experience in tobacco industry providing a total solution, and Miracom has consultants and engineers with great understanding in tobacco industry.

∙ Quality Mgt. & Operation Mgt. regarding all process starting from raw material income to finished product
∙ Ensure quality stabilization in main operations through real-time production monitoring
∙ Identify error source of defective goods, eliminate product failure factor & productivity improvement
∙ Ensure traceability of whole production through Lot History Mgt.
∙ Flexible and quick response to process changes


Miracom products for tobacco industry
∙ MESplus (Manufacturing Execution System)
∙ MESplus FMB (Line Monitoring System)
∙ APSplus (Advanced Planning & Scheduling)
∙ DACrux (Quality Management System)
∙ EAMplus (Enterprise Asset Management)
∙ Highway101 (Enterprise Application Integration)
 
 

Due to the constant issues regarding food safety, the food industry has been receiving a significant amount of interest and unfavorable attention from consumers. Therefore, the food industry has prioritized food safety issues by developing strict rules and restrictions. This step will be crucial for the success and advancement of the food industry.




Miracom products for tobacco industry
∙ MESplus (Manufacturing Execution System)
∙ MESplus FMB (Line Monitoring System)
∙ APSplus (Advanced Planning & Scheduling)
∙ DACrux (Quality Management System)
∙ EAMplus (Enterprise Asset Management)
∙ Highway101 (Enterprise Application Integration)