How you apply your engineering, operations and management skills to the complex problems in your industry is key to the value you bring. Count on our solutions for the tools, talent and domain knowledge that will amplify your contribution.
Few industries are more tightly regulated than life science manufacturing.
Whether producing pharmaceuticals, neutraceuticals, biotechnology or medical devices and equipment, life sciences manufacturing facilities must adhere to strict US FDA regulations such as 21 CFR Part 11, which requires that all manufacturing software have sound security procedures, done-by/checked-by capabilities and electronic signatures. Life sciences companies are often dependent on a handful of blockbuster drugs that are associated with the corporate brand, so protecting brand integrity is absolutely critical.
They must follow Current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP) and meet rigid operational standards. They must be prepared to produce accurate, reliable and tamper-proof documentation and Electronic Batch Records (EBR).
The patent clock starts ticking from the day of filing and once a product is ready for market it must go into manufacturing quickly with volume scaled up to meet market needs. our operations modules standardize operations oversight, including batch recipe management, workflow software for SOP implementation and tools for production startup and variance reduction. This allows life sciences companies to go from lab to full-scale reduction quickly.
Our Software Helps Implement Optimal Manufacturing Practices That Result In Operational And Process Improvements While Also Simplifying Compliance.
Cost-Effectiveness with System Platform
Compliance is not enough; life sciences companies must also be efficient and profitable. Our solutions help record machine performance and downtime, collect and correlate production data and manufacturing information and track all materials and utilities used to help understand the cost-effectiveness of operations.
International and Regional Customers
Operations Visibility Applications
- Food and Beverage SCADA Software
- Machine HMI
Operations and Process Control Applications
- MES-Operations Management
- MIS-Data Collection, Reporting & Analysis, Business Intelligence
- Batch management Formulation and Execution
Compliance and Quality Applications
- MES-Quality Management
- Business Process Management-Automated Workflow
Line and Equipment Performance Management Applications
- MES-Performance Management
Availability in Life sciences
Increasing Productivity And Profitability
Life sciences manufacturing companies rely on consistency and automation to meet strict regulations and rigid operational standards. Any small amount of unplanned system downtime can result in a decline in product quality and brand reliability. Stratus prevents system failure with operationally simple continuous availability solutions designed to keep pharmaceuticals, medical technology and biotechnology manufacturing operations running smoothly and always on.