Built for Compliance

Adhering to the highest industry standards for quality, safety, and data integrity.

Industry-Leading Standards

EN 12830

Temperature Recorders

  • ±0.5°C accuracy
  • 30-second measurement interval
  • Tamper-proof data logging

ISO 15189

Medical Laboratory Quality

  • Full chain of custody
  • Digital signatures for confirmations
  • Comprehensive audit traceability

EU GDP

Good Distribution Practice

  • Real-time monitoring
  • Automated deviation alerts
  • Temperature mapping support

GDPR

Data Protection

  • EU data centers and residency
  • 256-bit encryption
  • Granular access controls

Key Compliance Features

Continuous Monitoring

Ensure constant oversight of critical parameters with real-time data collection.

Instant Alerts

Receive immediate notifications of any deviations via SMS, email, and push.

Audit Traceability

Maintain an immutable record of all system actions with full traceability.

Digital Signatures

Authenticate records with secure electronic signatures for full accountability.

Automated Reports

Generate compliance reports automatically, ready on-demand or by schedule.

Calibration Management

Track and manage device calibrations for ISO compliance and accuracy.

Security First

256-bit encryption for data at rest and in transit

Dedicated EU data centers for data residency and privacy

99.9% uptime guarantee for uninterrupted operations

Regular third-party security audits and certifications

Frequently Asked Questions

Are data logs accepted by regulators?

Curesh data logs and reports are designed to support regulatory inspections and audits, including requirements aligned with EN 12830, ISO 15189, and EU GDP. Final acceptance always depends on the customer's operational procedures and the inspecting authority.

How long is data retained?

Data retention depends on your plan: Trip Compliance: 90 days, Compliance Pro: up to 7 years, Enterprise / GDP+: lifetime or custom retention. Retention periods are configurable to match regulatory and organizational requirements.

Can I export audit records?

Yes. Compliance reports and audit records can be exported in formats such as PDF and CSV. Bulk exports, automated reports, and advanced analytics are available on higher-tier plans.

What about digital signature validity?

Curesh supports advanced electronic signatures with timestamps and cryptographic integrity to ensure traceability and auditability. Signature validity and legal classification depend on customer configuration and applicable regulatory requirements.

How are calibration records maintained?

Calibration certificates issued by manufacturers or accredited laboratories are stored digitally with full traceability. The system tracks calibration validity periods and provides reminders to help maintain continuous compliance.

Need Compliance Documentation?

Our team is ready to provide you with all the necessary information and support.

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Compliance & Certifications | Curesh Cold Chain Platform | Curesh