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