Validated Data Integrity

Secure Data Integrity with Immutable Cold Chain Records

TrueCold provides a cryptographically secure audit trail for pharmaceutical logistics, ensuring your temperature data remains untampered from point of origin to patient delivery.

  • Full 21 CFR Part 11 compliance ready
  • Automated audit trail generation
  • Encrypted multi-node data storage

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The Standard for Verified Compliance

Our platform creates immutable cold chain records by utilizing advanced encryption protocols to lock temperature readings the moment they are captured. This eliminates the risk of human error or intentional manipulation, providing quality teams with 100% confidence in their disposal decisions and regulatory filings.

Tamper-Proof Data

Every data point is signed and hashed, creating a permanent ledger that cannot be altered or deleted by unauthorized personnel.

Regulatory Alignment

Designed to exceed global requirements for GxP environments, ensuring your organization stays ahead of evolving audit standards.

Absolute Visibility

Access historical records instantly with granular detail, including sensor calibration status and hardware battery levels.

How We Secure Your Records

1

Real-Time Capture

IoT sensors transmit encrypted data directly to the cloud without intermediate human interaction.

2

Digital Hash

The record is processed through a cryptographic hashing function, creating a unique digital fingerprint.

3

Permanent Archival

Data is stored across redundant secure nodes, providing a permanent and verifiable audit history.

Automated Compliance for Quality Teams

Stop wasting hundreds of manual hours on spreadsheet reconciliation and audit preparation. TrueCold transforms your data into a strategic asset that proves product efficacy automatically.

Industrial temperature sensors producing immutable cold chain records for pharmaceutical storage

Why Leaders Choose TrueCold

Unmatched Security

Our zero-trust architecture ensures that only authorized stakeholders can view data, while no one can modify it.

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Rapid Deployment

Deploy our pre-validated hardware and software in days, not months, with full IQ/OQ support provided.

Global Scalability

Monitor records across continents from a single centralized dashboard with localized alert management.

Compliance Questions

How do immutable records differ from standard cloud storage?
Standard cloud storage allows for administrative edits and deletions. Immutable cold chain records are stored in a write-once, read-many (WORM) format, meaning once the data is committed, it cannot be changed even by system administrators, providing a truly objective record for auditors.
Is TrueCold 21 CFR Part 11 compliant?
Yes, our platform is designed specifically for pharmaceutical quality requirements. We include electronic signatures, detailed audit trails, and strict access controls to ensure your operations remain fully compliant with FDA and EMA regulations regarding digital data management.
What happens if a sensor loses connectivity?
Our hardware includes significant on-board memory to cache data locally. Once connectivity is restored, the buffered records are uploaded with their original timestamps and verified against a cryptographic checksum to ensure data integrity remained intact during the transmission gap.

Ready to Secure Your Cold Chain Data?

Join the world's leading life science companies in adopting the gold standard for data integrity and regulatory compliance.