Skip to main content

Compliance Center

Audit-Ready Cold Chain Monitoring for Pharma, Food & Logistics

Data integrity is non-negotiable. Seemoto transforms cold chain monitoring into an audit-ready compliance asset, engineered to meet the strictest global standards.

Why Compliance Matters

In regulated industries, data accuracy and traceability are critical. We deliver secure, auditable, and transparent data every step of the way.

5-Year Data Retention

Secure cloud archiving meets long-term pharma and food safety retention clauses.

Audit Trail

Fully traceable logs of every user action, alarm, and corrective measure.

Calibration

Factory-calibrated sensors with EN 13485 accuracy.

Zero Data Loss

Gateways buffer data during outages to ensure continuous records.

Standards at a Glance

Seemoto supports the most demanding regulatory frameworks across pharma, food, and logistics.

StandardKey FocusSeemoto Capability
GDPPharma Supply Chain IntegrityContinuous monitoring, deviation reports & route validation for storage and transport
GMPManufacturing Quality ControlValidated environmental data, real-time deviation management & quality system integration
EN12830Temperature Recording AccuracyClass 1 certified TS & THS sensors, IP68-rated, -196°C to +150°C range
HACCPFood Safety Hazard PreventionAutomated CCP monitoring, instant hazard alerts & digital history logs
FDA 21 CFR Part 11Electronic Records & SignaturesRole-based access, electronic signatures & unalterable time-stamped audit trails

Compliance Standards in Detail

Each standard addressed with purpose-built monitoring, reporting, and validation capabilities.

Good Distribution Practice

Ensure product integrity across the entire supply chain. Seemoto provides continuous, validated monitoring for storage and transport, fully aligning with EU GDP guidelines (2013/C 343/01) for temperature-sensitive pharmaceuticals.

Good Manufacturing Practice

Maintain strict environmental control in production areas and cleanrooms. Seemoto delivers the validated data integrity and real-time deviation management required for GMP-regulated manufacturing.

EN12830 Standard

Rely on certified accuracy. All Seemoto TS and THS sensors are EN12830 Class 1 certified, ensuring precision for the entire cold chain from -196°C to +150°C.

HACCP Food Safety

Automate your food safety plan. Replace manual clipboard checks with wireless monitoring to control Critical Control Points (CCPs). Instant hazard alerts prevent spoilage.

FDA 21 CFR Part 11

Secure your digital records. Seemoto provides role-based access, electronic signatures, and unalterable, time-stamped audit trails for full FDA compliance.

Data integrity and security

Security

Uncompromised Data Integrity & Security

End-to-End Encryption

Data is encrypted from the sensor to the gateway and throughout transmission to the cloud, preventing interception or tampering.

Role-Based Access Control

Granular user permissions ensure only authorized staff can view data, acknowledge alarms, or edit settings.

Immutable Audit Trails

Every system event including logins, alarm handling, and configuration changes is permanently logged and time-stamped.

Secure Cloud Retention

Automated 5-year data archiving meets long-term retention requirements for FDA and EU regulations.

Resources

Partner Support & Validation Resources

Compliance is a team effort. Seemoto empowers our partners and customers with ready-made validation toolkits and comprehensive training.

  • Access our Partner Portal for IQ/OQ templates, user manuals, and calibration certificates
  • Rely on our dedicated support team for technical and regulatory guidance during audits
Visit Trainer Portal
Partner support

Frequently Asked Questions

Ready to Simplify Compliance?

Contact our team to learn how Seemoto can help you meet regulatory requirements with confidence.