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Monitoring designed to support regulated laboratory environments
In regulated pharmaceutical, biopharmaceutical, and clinical laboratories, monitoring systems must support structured
workflows, traceable actions, and documented processes aligned to applicable regulatory standards.
Thermo Scientific remote monitoring solutions are designed to support compliance workflows by enabling audit-ready
monitoring, role-based controls, and structured data capture.
Supporting FDA 21 CFR Part 11-Aligned Workflows
Certain regulated environments require systems that support electronic records, user accountability, and traceable audit trails.
Smart-Vue Pro
Smart-Vue Pro is designed as a validated environmental monitoring system that can support workflows aligned to FDA 21 CFR Part 11 where required.
Key elements include:
- Audit trail functionality
- Role-based access controls
- Centralized record retention
- Structured response workflows
- Documented event history and acknowledgments to help you meet regulatory requirements according to your SOPs, cGxP, 21 CFR Part 11, ISO 17025, CE, FCC, ISED, WPF (India), CMIIT (China), EMC and electrical safety, among other standards.
Connect Edge
Connect Edge monitors equipment telemetry and transmits raw data to cloud or on-premise systems. It does not function as a standalone validated monitoring system; instead, it integrates with customer-hosted compliance environments that may already be validated or aligned to 21 CFR Part 11 requirements.
This architecture supports laboratories that maintain validated systems of record and require centralized equipment telemetry integration.
Data Security & System Integrity
Thermo Scientific remote monitoring solutions leverage the Thermo Fisher Connect Platform, built in alignment with Thermo
Fisher Scientific's Cybersecurity Program and hosted on the Amazon Web Services™ (AWS) cloud infrastructure.
The platform incorporates multiple layers of security and operational safeguards.
Flexible Deployment for Regulated Environments
Remote monitoring solutions support:
- Cloud-based deployment
- On-premises configurations
- OPC UA-based integrations
- Alignment with existing IT governance frameworks
Deployment flexibility enables laboratories to align monitoring
infrastructure with internal compliance and validation policies.
Designed for Structured Compliance Workflows
Monitoring systems in regulated laboratories must support more than alerts.
They must enable:
- Defined escalation paths
- Traceable corrective actions
- Documented review processes
- Predictable workflows aligned to SOPs
Smart-Vue Pro provides built-in workflow structure.
Connect Edge integrates monitoring data into validated enterprise systems.
Frequently Asked Questions
Does Thermo Fisher provide 21 CFR Part 11-compliant systems?
Smart-Vue Pro is designed to support workflows aligned with FDA 21 CFR Part 11 requirements. Implementation and validation
are the responsibility of the laboratory.
Is Connect Edge 21 CFR Part 11 compliant?
Connect Edge transmits equipment telemetry data to cloud or on-premise systems and integrates with customer-hosted
compliance environments.
Where is monitoring data stored?
Data can be stored in cloud environments hosted on AWS or in on-premises systems using supported integration models,
including OPC UA.
How is monitoring data protected?
Monitoring data is protected through layered encryption, network segmentation, role-based access controls, scheduled audits,
and secure infrastructure management.
Support compliance with confidence
Whether your laboratory requires a validated monitoring system or integration into an existing compliance architecture, Thermo Scientific remote monitoring solutions are designed to support structured workflows, secure data management, and regulatory
For Research Use Only. Not for use in diagnostic procedures.