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Advanced it platform for production management in pharmaceutical industry

A completely new product mepis ebr will be developed. Mepis-ebr is advanced configurable information platform for the management and monitoring of production in the pharmaceutical industry. It will provide powerful tools for system integrators to customize solutions for particular pharma client.

Life science industry (pharmaceutical firms, biotech companies, medical device makers) is one of the fastest growing industrial segments. Manufacturers in this industry are facing continuous pressure to reduce cycle time and cost and to increase quality and yields. Production is usually highly automated and procedures are very complex. The life science industry is globally also one of the most regulated industries. Besides risk management itself, regulatory compliance covers complete control of the entire product development and delivery chain. Visibility of the production process is the key to turning regulatory reporting information into business insights. Information technologies are therefore the key enablers for efficient and effective management of production and supply chains in life science industry. Within IT systems huge amounts of process data from different sources (automation and IT systems supporting production) are collected and analytically processed in order to get a deep real time view of production processes. Unfortunately, today's systems are far too complex and inadequate to address all the challenges of the life science industry. Implementation procedures are time consuming and expensive. Integration of different production equipment is very complex. Systems are not configurable and consequently can be implemented only by vendors themselves; System Integrators cannot perform the implementation. If the production data is not organized and handled correctly, operators and managers cannot react promptly. Therefore, production is less efficient, less flexible and less controlled. This can result in mistakes during the production processes that can affect end products and cause catastrophic consequences for both companies and users of their products. The life science industry is confronted with the demand for IT solutions/products that support optimization and regulatory compliance of production processes. Metronik and Com-Forth are companies already presented on the world market of IT solutions for the manufacturing management in pharmaceutical industry. For the purpose of this kind of industry we have developed solutions which include key features: material flow control, batch record, production analysis. However, existing solutions are not configurable and are not productized (we cannot sell them to System Integrators) and miss functionality, such as serialization (unique product labeling), support for managing the energy efficiency of production, central production portal that comprehensively manages key indicators of production, intelligent production planning, management of availability and maintenance of devices, tools and machines. We observed that the existing solutions are technologically obsolete (it is not configurable and cannot be productized, complexity of implementation and maintenance is thus hindering the breakthrough to international markets, cannot System Integrator ), does not work on smart devices and does not support the new operating systems. Therefore, we will develop a completely new product called MePIS EBR (EBR = Electronic Batch Record) - advanced information platform for the management and monitoring of production in the pharmaceutical industry. The main technological advantage and innovation of the new IT platform compared to the already existing products, is inovative technology enabling complete configurability. MePIS-EBR offers configurable development environment (development platform) with built-in functions for supporting the pharmaceutical industry with an emphasis on paperless production and EBR (Electronic Batch Record). The configurability empowers System Integrators to implement highly functional solutions for pharmaceutical and life science clients and to customize them to the needs of particular clients without programming. Currently there are no similar platforms on the market, therefore we assess that the product can make a major and successful breakthrough in the markets all over the globe. Potential customers are Life Science companies globally (mainly pharmaceutical producers) and System Integrators working for Life Science companies. By using the MePIS-EBR product end users will gain: complete traceability and genealogy of products, complex process management and analytical tools, electronic based process workflow which will decrease human errors and speed up production reports, work in process information allowing users to understand production bottlenecks, material flow and material consumption information, advanced analytical tools enabling process optimization, quality control support and regulatory compliance fulfilment, support for anti-counterfeiting to avoid distribution and use of illegal products. Through the use of innovative implementation model wider range of life science companies will be addressed.
Acronym: 
MePIS-EBR
Project ID: 
9 570
Start date: 
01-01-2015
Project Duration: 
36months
Project costs: 
910 000.00€
Technological Area: 
Data Processing / Data Interchange, Middleware
Market Area: 
Other Medical / Health Related

Raising the productivity and competitiveness of European businesses through technology. Boosting national economies on the international market, and strengthening the basis for sustainable prosperity and employment.