Helping the pharmaceutical industry transform
Digital solutions for the pharmaceutical value chain
The industry is under pressure from all angles: customers, competition, pricing, patient demands, cost of research, and increasingly complicated and global regulatory demands. It's also traditionally struggled to attract the premium talent it needs. With the help of digitalisation, pharmaceutical manufacturers are able to transform their operations with an integrated data landscape from drug discovery, through primary and secondary processing to patient delivery.
Digital solutions for the entire value chainDigitalization changes all areas of life: The way we stay informed, the way we travel, the way we buy things – and the way we manufacture products. The pace of innovation and the ability to disrupt are becoming key success factors in global competition. The pharmaceutical industry is no exception. Smarter products and experiences are challenging the way drugs have been produced until now – and at the same time, they open up new business opportunities.
Taking the fast lane to integrated operations: Solutions for digitalization from product to production
To address the challenges of future R&D and production requirements, the pharmaceutical industries needs solutions that help make operations more flexible and productive. Digitalization can help cut time to market, and that further improve quality by supporting right-first-time production through data integrity and consistency across the value chain. Additionally, digitalization benefits the industry by providing data integration, analysis and simulation capabilities and will help streamline today's operations and open up business opportunities for the future.
Accelerating time to market with integrated engineering and operations
Digitalization is a vital instrument in picking up speed during a crucial phase of your value chain: the transfer of a new drug from R&D to production. With our solutions for integrated engineering and operation, you can streamline process development and maturity and increase production flexibility and asset utilization at the same time – by ensuring data consistency across the entire lifecycle. With COMOS, Siemens delivers a comprehensive software solution for the optimal integration of engineering and operation. Using a global, single data platform ensures consistent documentation and highly efficient plant operation from the planning stage onward. Combined with SIMATIC PCS 7, we can extend this integrated approach to the automation level, providing a central data management environment for plant engineers and operators. Your benefit: reduced time to market at lower costs and with improved quality.
Agile, efficient and flexible processes with digital solutions
Drugs are increasingly produced in highly specific, individual formulations – often in amounts of less than 100 dosages. Consequently, batch changes must be very fast and flexible, and modular plant designs require a high level of production flexibility to serve an increasingly personalized demand for pharmaceutical products. With SIMATIC IT eBR, Siemens offers a software solution for electronic master batch record (eBR) management that enables native integration between the manufacturing execution system (MES), the MOM portfolio and the distributed control system (DCS) using SIMATIC PCS 7 and SIMATIC BATCH. SIMATIC IT eBR expedites the design, execution, review and release of master batch records (MBR) and electronic batch records (eBR). It also enhances MBR design flexibility by providing all the master information from SIMATIC BATCH to the MES design tool. With our SIMATIC IT Preactor production planning and scheduling software products, you can improve the synchronization of your manufacturing processes, giving you greater visibility and control to increase utilization and on-time delivery while reducing inventory levels and waste. Our SIPAT solution for process analytical technology integrates the PAT tools with the process control system and enables the chemometrical calculations in real time to achieve real time release – cutting time to market significantly. And finally, our SIMIT simulation software will help you test and assess the impact of changes on production in a virtual environment without risks for process and equipment. It will speed up process changes through virtual commissioning and advanced training for your staff – for a better process right from the start.
Better decisions thanks to smarter data
With markets becoming more volatile and innovation driving production, it is increasingly vital to use the right tools to make the right decision for your operations: Where do I have the capabilities to squeeze in this extra batch? How can I produce it with the optimum resources? Digitalization can provide the tools that help answer these questions right here and now. At the plant and process level, our modular SIMATIC WinCC monitoring and operation system provides a detailed insight into current and scheduled processes and networks seamlessly with our manufacturing IT. It also tracks all operations for documentation and review. Our XHQ Operations Intelligence platform aggregates, relates and presents operational and business data in real-time to improve enterprise performance. Through XHQ, you have a single and coherent view of information for all operations in your pharmaceutical production units. This enables real-time performance management and decision support.
IT security is both mandatory and key success factor
In the pharmaceutical industry, digitalization offers enormous potential for improving competitiveness. But it also poses major risk. That’s why the digital networking of production facilities must always feature effective measures to close security gaps and protect networks from external attacks.
To achieve this, it’s necessary to initiate action in all areas simultaneously – from the operational level to the field level and access control to copy protection. We use the defense-in-depth concept. It’s a depth-staged defense following the recommendations of ISA99 / IEC 62443, the leading security standard in industrial automation.
Defense-in-depth relies on three pillars: plant security, network security, and system integrity. Classic asset protection blocks physical access, while security for network and system integrity shields against cyber attacks and unauthorized access by users or non-employees.
Cyber attacks can have especially devastating consequences for players in the pharmaceutical industry. Consider the significance of intellectual property protection, where data theft can quickly cause financial damage in the millions. It’s clear that in a connected world, IT security is a basic prerequisite for plant availability and profitability – and thus for lasting success in global competition.