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Seemoto

Compliance-centrum

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.

Waarom compliance belangrijk is

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.

Normen in een oogopslag

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

StandaardBelangrijkste focusSeemoto Capability
GDPIntegriteit van de farmaceutische toeleveringsketenContinuous 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 Deel 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.

Goede distributiepraktijken

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.

Goede productiepraktijken

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 Norm

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 Voedselveiligheid

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 Deel 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

Onveranderlijke gegevensintegriteit en -beveiliging

End-to-End Encryption

De gegevens worden versleuteld vanaf de sensor tot aan de gateway en tijdens de volledige overdracht naar de cloud, waardoor onderschepping of manipulatie wordt voorkomen.

Role-Based Access Control

Gedetailleerde gebruikersrechten zorgen ervoor dat alleen bevoegd personeel gegevens kan bekijken, alarmen kan bevestigen of instellingen kan wijzigen.

Immutable Audit Trails

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

Secure Cloud Retention

Geautomatiseerde archivering van gegevens gedurende vijf jaar voldoet aan de vereisten voor langdurige opslag volgens de regelgeving van de FDA en de EU.

Resources

Ondersteuning en validatiebronnen voor partners

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
Bezoek Trainersportaal
Partner support

Veelgestelde vragen

Ready to Simplify Compliance?

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