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

Data integrity is non-negotiable. Seemoto transforms environmental monitoring from a manual burden into an automated compliance asset. Our system is engineered to meet the strictest global standards, ensuring you are always ready for an inspection, whether by the FDA, EU authorities, or your own customers.

Why Compliance Matters

In regulated industries, data accuracy and traceability are critical. GDP, GMP, EN12830, HACCP, and FDA 21 CFR Part 11. We deliver secure, auditable, and transparent data every step of the way, minimizing the risk of product loss and failed audits.


Quick facts:

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

StandardKey FocusSeemoto
 GDPPharma Supply Chain IntegrityEnd-to-End Traceability: Automated deviation management and continuous logging for storage & transport, fully aligned with EU GDP guidelines.
 GMPProduction Quality AssuranceEnvironmental Control: Precision monitoring for cleanrooms and production areas to ensure strict manufacturing compliance.
 EN12830Sensor Accuracy & ReliabilityClass 1 Certified: Robust, waterproof (IP68) sensors validated for temperatures from -196°C to +150°C.
 HACCPDigital Data IntegrityAudit-Proof Records: Secure, unalterable electronic records with full audit trails, role-based access, and digital signatures.
 FDA 21 CFR Part 11Food Safety Risk ControlCCP Automation: Replaces manual logs with automated Critical Control Point monitoring and instant hazard alerts

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. Protect your license with automated deviation reports and route validation.

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. Seamlessly integrate environmental data with your existing quality systems.

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 deep freezers to +150°C ovens, our IP68-rated hardware provides the robust, independent verification auditors demand.


HACCP Food Safety

Automate your food safety plan. Replace manual clipboard checks with wireless monitoring to control Critical Control Points (CCPs) automatically. Instant hazard alerts prevent spoilage, while digital history logs ensure you pass ISO 22000 and health inspection audits effortlessly.

FDA 21 CFR Part 11

Secure your digital records. Seemoto provides the essential technical controls for FDA compliance: role-based access, electronic signatures, and unalterable, time-stamped audit trails. We ensure your data is authentic, retrievable, and ready for inspection at any moment.

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 (RBAC): 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 for full traceability.
Secure Cloud Retention: Automated 5-year data archiving meets long-term retention requirements for FDA and EU regulations.

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