Stay competitive and optimize your pharma production
Pharmaceutical and biopharmaceutical manufacturers are facing daunting technology changes such as cloud, big data, smart equipment, digitization and Industrie 4.0 / Industrial Internet of Things. These challenges are increased even more with fewer blockbuster drugs, emerging markets, shorter time-to-market and increased regulatory complexity. Frost & Sullivan research shows that the industry faced a large number of patent losses in recent years, which created intense competition from generic drug manufacturers and eroded profit margins.
Constant regulatory pressure
Added to this, is the constant regulatory pressure ensuring quality and safety in all manufacturing processes. Regulatory agencies, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) constantly monitor the pharmaceutical and biotech industries. The FDA requires manufacturers to provide greater transparency through audit trails and access control functions.
MES solutions gain importance
As a result, the need for cost-effective industrial automation processes, particularly MES solutions, is gaining importance to meet these requirements and to optimize pharma production. Manufacturers are adopting electronic execution, validation and batch recording systems. Frost & Sullivan points out that MES allows global integration across the value chain, thus enabling the tracking of material and product flow in compliance with FDA requirements. Global players are looking to harmonize and optimize their IT systems, while mid-sized companies are focusing on standardized MES products.
Best-in-class MES software
Werum’s manufacturing IT solutions cover all these needs. The core of their offering is the PAS-X manufacturing execution system (MES) that combines software, content and services. PAS-X ranks as the most functional complete MES in the market, enabling efficient manufacturing operation – especially critical within the pharmaceutical and biotechnology sectors. Specific IT solutions are available for manufacturing operations such as Track & Trace, KPI/OEE, and Weighing & Dispensing. These entry-level solutions can gradually be extended until manufacturers benefit from a full-scope PAS-X MES.
Future of pharma manufacturing
“Innovative solutions are an essential part of our future and will, to a great extent, help pharma manufacturers to maintain and expand their market position. In the context of digitization, manufacturing IT is getting a new focus. We will actively develop new solutions under the Industrial Internet of Things and Pharma 4.0 concepts, addressing the challenges of our customers, while paving the way to the future of pharmaceutical manufacturing,” says Rüdiger Schlierenkämper, CEO of Werum IT Solutions GmbH.