Increased regulation on food and drug safety play a major role in the market. According to title 21 Part 11 of the food and drug administration( FDA) which implies that all the processes audits, controls, system validations, electronic signatures and documentation are to be maintained in electronic format by all the pharmaceutical industries, biotech companies, medical device manufacturers and other FDA regulated industries.
Maintaining the system would be a major restraint for the batch management software. One on staff expert or two can maintain a simple batch application, however it becomes difficult to manage the software or the codes with a single expert as the complexity increases. Non availability of skilled workforce can restraint the company to proceed with the processes. Batch manufacturers need to shift to more advanced batch applications to be more efficient and cost effective. They need to be more responsive to the consumer needs and produce products more economically.
Evolution of business system integration will help the batch management software products and their market size. Closer integration with business systems, implementing analytical technologies and use of different working models and workflow engines anticipate major changes that will shape batch management products. Governments in developed economies are replacing custom batch solutions with other basic software.
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The manufacturers are enhancing the use of their systems while associating production by attempting to maintain product flexibility. There is a continuous growth in consumer goods and durables which leads to high demand for quality and variety increasing the implementation of Batch management software. Many of the manufacturing facilities have little to no automation infrastructure and are primarily operated manually. These factors enhance the deployment of BMS systems globally.
Batch management software can be segmented on the basis of their functionalities which includes recipe management and execution, production scheduling, historian and reporting, quality management, resource and inventory management. Wonderware Inbatch is a control system independent batch management system introduced to deploy BMS to run new product recipes, reducing the time to market and recipe validation efforts in regulated industries.
The major players in the market are pharmaceutical, biotech and chemical industries followed by food and beverage, pulp & paper, mining & metals, cement & glass. Geographically Batch management software market can be segmented as North America, Europe, and Asia pacific. The U. S. alone holds around 40 % of the global pharmaceutical market, six out of the total eleven countries are based in the country. Increased requirements