Verified Pharmaceutical supply chain audit trail and integrity.
Maintaining a continuous audit record is no longer optional. TrueCold provides a validated, immutable data history that ensures every temperature excursion is documented and addressed automatically.
- Full GAMP5 and 21 CFR Part 11 compliance
- Automated excursion reporting and root cause analysis
- End-to-end data integrity across all transit modes
Schedule Compliance Review
Book a technical walkthrough with our compliance team to secure your trail.
Defining the Digital Audit Record
A Pharmaceutical supply chain audit trail is a secure, chronological record that provides documented evidence of the sequence of activities that have affected at any time a specific operation, procedure, or event. In cold chain logistics, this means every degree of temperature change and every handoff must be timestamped and attributed to a specific sensor or user.
Immutable Logging
Secure data storage prevents any unauthorized modification of temperature logs, ensuring absolute honesty in regulatory submissions.
User Accountability
Every intervention, from alarm silences to sensor recalibrations, is tied to a specific user ID with a secure digital signature.
Real-Time Availability
Access your entire history instantly during surprise audits, eliminating the need to hunt through paper logs or disparate spreadsheets.
Three Steps to Audit-Ready Logistics
Automated Capture
IoT sensors transmit data directly to our cloud, removing human error from the data collection process entirely.
Integrity Validation
Algorithms verify data continuity and check for missing packets, ensuring there are no gaps in your monitoring history.
Instant Reporting
Generate GxP-compliant PDF reports with a single click, ready for immediate distribution to QA teams and inspectors.
Authoritative Compliance Infrastructure
TrueCold is designed by pharmaceutical quality experts to meet the rigorous demands of global regulatory bodies. We provide more than just data; we provide the peace of mind that your product integrity is backed by a robust pharmaceutical supply chain audit trail that stands up to scrutiny.
Why QA Teams Trust TrueCold
FDA-Validated Platform
Our software environments are pre-validated according to IQ/OQ/PQ standards, significantly reducing your internal validation workload.
Proactive Anomaly Alerts
Don't wait for a report to find an error. Real-time SMS and email alerts notify you the moment a deviation begins.
Global Interoperability
Integrate seamlessly with your existing ERP and WMS systems while maintaining a unified audit trail across all platforms.
Audit Trail Intelligence FAQ
How does TrueCold ensure data integrity in the audit trail?
We utilize encrypted transmission protocols and immutable storage databases. This ensures that once a temperature reading is recorded from a calibrated sensor, it cannot be altered or deleted by any user, meeting the "Alcoa+" principles required for pharmaceutical data integrity.
Is the platform compliant with FDA 21 CFR Part 11?
Yes, TrueCold includes all necessary technical controls for 21 CFR Part 11, including secure e-signatures, password aging, unsuccessful login lockouts, and a system-generated audit trail that records the date and time of operator entries and actions.
Can we use our own sensors with your audit trail system?
Our platform is hardware-agnostic. We can ingest data from a wide variety of qualified IoT sensors and data loggers, consolidating them into a single, standardized pharmaceutical supply chain audit trail for your entire global operation.
Secure Your Compliance Future Today
Stop worrying about missing data or failed audits. Implement a foolproof pharmaceutical supply chain audit trail with TrueCold.