MES Reduces Operational Costs
There are potential applications for MES in both formulation and packaging with the end goal of getting from tech transfer to production faster and with the appropriate documentation. Tracking SKUs can be a difficult task considering all the formulation types, dosage strengths, packaging, labeling, and language requirements. A strong MES solution can help with inventory and supply chain management, as well as other functional activities such as resource planning, scheduling, and managing overall equipment effectiveness. Additionally, MES can drive lean manufacturing; thereby reducing waste, re-work, and downtime.
Generics and CMOs dedicate their business to providing services such as drug development, manufacturing and packaging for pharmaceutical companies who need production scalability. A source of long development and production lead times for product lifecycle is from data—especially when manufacturers have islands of automation. An ISA 95 MES solution can help integrate all levels of manufacturing systems—instrumentation (L0- PLCs, DCS, BAS), SCADA systems (L2), LIMS (L3), and ERP (L4)—to collect, measure, and analyze data.
Managing the challenges of data integration for efficient manufacturing is one aspect of Generic and CMO business. The most impactful use case for an MES solution is compliance. In 2022, the second most Inspection/FDA 483 observation was FDA 21 CFR 211.192 Cite ID 2027—investigations of discrepancies and failures. By sufficiently collecting, measuring, and analyzing data with an ISA 88 MES solution, batch reporting can be completed sooner, but most importantly, to meet compliance. Put our decades of MES experience to work for your data integration, recipe authoring, and batch reporting needs—regardless of your platform.
Here’s the big deal:
When you’re doing 5,000 production orders per year, saving 2 hours per order translates into 10,000 hours saved.
