Biopharma Temperature Monitoring Technology: What to Look For

Selecting the right temperature monitoring technology for biopharma products is high-stakes. The ideal solution balances precision, validation, security, and usability to ensure product quality and regulatory compliance.

Evaluation Criteria

When evaluating monitoring technology, consider these critical aspects:

• Sensing: Look for high accuracy, calibration traceability, and minimal drift over time.
• Connectivity: Ensure real-time monitoring options, offline buffering, and global coverage for distributed supply chains.
• Validation: Support for IQ/OQ/PQ templates and Part 11-compliant e-signatures is essential.
• Data Integrity: Maintain ALCOA+ standards, immutable logs, and robust access controls (RBAC/SSO).
• Analytics: Choose platforms with risk scoring, lane benchmarking, and packaging guidance to prevent excursions before they occur.

How TrueCold Simplifies It

TrueCold provides an end-to-end solution for biopharma cold chain monitoring:

• Validated platform with certified device integrations
• Secure sync, encryption, and fine-grained access control
• Automated deviation → CAPA workflows and audit-ready reports
• Actionable insights for continuous stability improvement

Key Takeaways

• Prioritize accuracy, validation, and integrity by design
• Ensure global connectivity with offline resilience
• Use analytics proactively to prevent excursions, not just record them

Book a Demo

Standardize your monitoring technology with TrueCold and gain full visibility into your cold chain. Contact us to schedule a demo.