In the life science industry, where precision, regulatory compliance and quality are non-negotiable, STIWA Shopfloor Software aid consistent product quality and robust traceability across all manufacturing processes.
Real-time data collection builds comprehensive audit trails, while meticulously controlled processes for after-sales support ensure every component meets the highest standards.
Advanced analytics minimize downtime in critical environments. This detailed traceability streamlines complaint management, enabling quick, cost-effective resolutions and driving continuous improvement. With STIWA, you can confidently meet the sector's rigid demands, reduce the compliance burden, and drive innovation in medical technology.
Features for Life Science
- Regulatory Compliance: We support compliance with EN ISO 13485 and ISO 14971.
- End-to-End Traceability: Achieve complete visibility with unique IDs for materials, processes, operators, and serial numbers, ensuring an unbroken audit trail.
- Recall and After Sales Management: Swiftly identify affected batches down to the serial numbers within seconds, enabling compliant documentation for authorities and customers and facilitating rapid, cost-effective complaint handling.
- Comprehensive Process Support: STIWA Software streamlines production planning and control, captures vital production data and measurements, and drives data analysis for continuous improvement of both production and quality assurance processes. This comprehensive support extends to ensuring seamless post-market traceability of finished products.
- Real‑Time Data Capture for complete audit trails from production start until after-sales.
- Advanced Analytics: Minimize unplanned downtime in critical healthcare environments through advanced analytics capabilities, ensuring maximum machine availability.
- Automated Alarm & Downtime Analytics: Benefit from automated analysis of alarms and downtimes.
- Configurable Escalation Management: Ensure critical events are addressed promptly by automatically routing alerts and defining clear response protocols based on severity and impact. – coming soon