Streamline Your Electronic QP Declaration
Accelerate pharmaceutical batch release with TrueCold. Our platform automates the synthesis of cold chain data into a single, validated Electronic QP declaration to ensure total regulatory compliance.
- Automated temperature data aggregation
- Real-time excursion risk assessments
- Full audit traceability for EU Annex 16
Schedule Compliance Review
Book a technical walkthrough with our compliance team to see how we digitize batch release.
What is an Electronic QP Declaration?
An Electronic QP declaration digitizes the manual verification process required by a Qualified Person to confirm that temperature-controlled medicinal products have been stored and transported according to GxP standards. By centralizing disparate loggers and sensors into a single source of truth, TrueCold removes the risk of human error and accelerates the final disposition decision.
Data Integrity
Ensure every data point in your Electronic QP declaration is tamper-proof and directly pulled from validated IoT hardware.
Regulatory Agility
Stay ahead of EU and FDA mandates with automated documentation that meets the most stringent audit requirements.
Risk Reduction
Identify temperature deviations instantly, allowing the QP to focus only on batches that require specific investigation.
The Digital Batch Release Playbook
Unified Data Capture
TrueCold integrates with any IoT sensor to collect continuous temperature data across the entire supply chain journey.
Automated Audit
Our engine checks data against pre-defined stability profiles, highlighting any excursions that impact product quality.
Digital Declaration
The Qualified Person reviews the summary dashboard and generates a signed Electronic QP declaration in minutes.
Total Compliance Control
TrueCold provides the technical infrastructure needed to maintain a high-trust cold chain. By digitizing the Electronic QP declaration, we enable quality teams to operate with 100% visibility into product handling history, reducing the time from delivery to market availability.
Why Leading Pharma QAs Choose TrueCold
End-to-End Visibility
Stop managing silos. Consolidate warehouse, transport, and last-mile data into one declaration portal.
Validated for Life Sciences
Our software is GAMP 5 compliant and ready for FDA 21 CFR Part 11 electronic signature requirements.
Proactive Anomaly Alerts
Don't wait for batch release to find issues. Receive real-time alerts the moment a deviation occurs.
Frequently Asked Questions
How does this support EU Annex 16 compliance?
TrueCold ensures that all data required by the Qualified Person for certification is consolidated, accurate, and readily accessible. The Electronic QP declaration provides the necessary evidence that each batch has been manufactured and tested in accordance with GMP and the marketing authorization.
Is the Electronic QP declaration legally binding?
Yes, our platform uses secure digital signatures and audit trails that comply with 21 CFR Part 11 and EU Annex 11, making the Electronic QP declaration a legally valid document for batch release in regulated markets.
Can we integrate TrueCold with our existing ERP?
Absolutely. Our API-first architecture allows for seamless integration with SAP, Oracle, and other enterprise systems to push declaration status directly into your logistics and inventory management workflows.
Ready to Modernize Your Compliance?
Join the world's leading pharmaceutical companies using TrueCold to automate their Electronic QP declaration process.