sphere connect
A smart, 21 CFR Part 11–compliant solution connecting SKAN isolators to the digital world
sphere connect
A smart, 21 CFR Part 11–compliant solution connecting SKAN isolators to the digital world
sphere connect – Where isolator data becomes GMP intelligence.
sphere connect is a scalable data management platform for the integration, analysis, and visualization of process data in GxP-regulated production environments. The platform connects a wide variety of data sources, prepares the information in a structured manner, and makes it globally accessible.
Your Benefits
From Data to Insight
sphere connect makes data meaningful through intelligent analysis.
Accelerated Time-to-Production
Significant reduction in integration and validation time.
Regulatory Compliance
21 CFR Part 11 Readiness
Extensive Data Archiving
Ensure data integrity - complete and stored for long-term compliance.
Easy Integration
Seamlessly connects all isolator process data, alarms, and events to Data Historian e.g. AVEVA PI.
Human Friendly Asset Model
Effortless navigation through your isolator data.
Automated Reporting
Automatically generated reports with real-time notifications.
User-friendly Dashboards
Intuitive interfaces for visualizing alarms, events and batch data.
Real-time View
Navigate your real-time isolator data from wherever you are.
Data Flow
1.
Real-time Alert Detection
The isolator's monitoring system detects a temperature anomaly and immediately generates digital alerts with notification and reports.
2.
Instant E-Mail Notification
Delivers critical alarms and events in real time, ensuring faster reactions, minimizing risks, and strengthening overall operational reliability.
3.
Instant Data Transfer
Sensor data flows seamlessly from the physical system to your data management system and dashboard - all in real-time.
4.
Remote Access
Quality managers can review critical parameters anywhere, anytime. Complete traceability at your fingertips.
5.
QA-Ready Documentation
All data is automatically compiled into audit-ready reports with fully compliant documentation – saving weeks of manual work.
6.
Batch Report
sphere connect automatically compiles batch data into a clear, compliant report. It supports GMP requirements, improves visibility, and provides reliable documentation for audits and process optimization.
From real-time isolator data to long-term storage of data
Data Source
Collect & Archive Module Data Archive
Included
- Process data collection (via OPC UA)
- Alarm and events collection (via SQL protocols)
- Pre-configured data points
- Customer tag naming convention
- Pre-validation documents
Benefits
- Time saving
- Data integrity
- Faster validation
Contextualize Module Asset Framework
Included
- Asset framework template
- Data categorization
- Pre-validation documents
Benefits
- Time saving
- Standardized asset model
Visualize Module Visualization
Included
- 3 pre-configured dashboards - Isolator - Wireless Glove Testing
Benefits
- Real time visualization of all relevant isolator data
Customer Data
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sphere connect transforms isolator data into digital intelligence.
The modular digitalization platform captures production data, alarms, and events, structures them into compliant data records, and provides real-time performance data through intuitive dashboards. As expert for isolators, SKAN delivers more than connectivity. We turn your isolator data into a reliable digital foundation that supports GMP-driven, traceable, and efficient production.
Thank you for exploring.
We'd love to continue this conversation about how to support you with your digitalization strategy.
