Validated FDA 21 CFR Part 11 Electronic Records
Maintain mission-critical data integrity across your global cold chain with TrueCold. We provide the technical controls and procedural documentation required for FDA 21 CFR Part 11 electronic records compliance.
- Automated, immutable audit trails for every event
- Secure electronic signatures for record approval
- High-availability redundant data storage
- Full validation package for regulatory audits
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Book a technical walkthrough with our compliance team to review our GxP protocols.
Compliant Data Management
In a regulated pharmaceutical environment, electronic records are the backbone of product quality. TrueCold ensures that every temperature reading and system interaction is captured, secured, and stored in strict accordance with FDA 21 CFR Part 11 electronic records mandates, eliminating manual documentation risks.
Attributable Records
Every action is uniquely identified to an individual, ensuring full accountability across your entire quality management workflow.
Legible & Permanent
Records are stored in human-readable formats and retained for the full lifecycle required by regulatory bodies.
Contemporaneous Logs
Data is recorded at the moment of occurrence, providing a precise and real-time history of your cold chain environmental conditions.
Compliance Implementation Playbook
System Configuration
We align TrueCold settings with your internal SOPs, establishing access controls and signature hierarchies.
IQ/OQ Validation
Our team executes formal Installation and Operational Qualifications to prove the system meets compliance specs.
Audit Readiness
Automated reporting tools generate audit-ready documentation for FDA 21 CFR Part 11 electronic records in seconds.
Uncompromising Data Integrity for Global Logistics
When shipping life-saving therapeutics, there is no room for data gaps. TrueCold’s cloud architecture is designed specifically to support FDA 21 CFR Part 11 electronic records requirements, protecting your product's release and your company's reputation during rigorous regulatory inspections.
Why Quality Teams Choose TrueCold
Time-Stamped Audit Trails
Detailed logs of every user action, login attempt, and configuration change, ensuring nothing is ever hidden or altered.
Secure Access Control
Role-based access controls (RBAC) ensure that only authorized personnel can generate or sign FDA 21 CFR Part 11 electronic records.
Predictive Quality Alerts
Go beyond compliance with AI-driven monitoring that detects potential excursions before they happen.
Compliance FAQ
What are the key requirements for Part 11 compliance?
The regulation requires controls for closed and open systems, including validation, the ability to generate accurate copies of records, and protection of records to enable their accurate and ready retrieval throughout the record retention period. TrueCold manages these requirements through technical safeguards and complete validation documentation.
How does TrueCold handle electronic signatures?
TrueCold implements legally binding electronic signatures that are linked to their respective electronic records. Each signature includes the printed name of the signer, the date and time, and the meaning of the signing action, fulfilling all FDA 21 CFR Part 11 electronic records criteria.
Do you provide validation documentation?
Yes. We offer a comprehensive validation package that includes IQ, OQ, and PQ documentation. This package is designed to significantly reduce the time and effort your internal quality team must spend on system verification during deployment.
Ready to Automate Your Compliance Workflow?
Join the world's leading pharmaceutical companies who trust TrueCold to secure their most sensitive temperature data.