#21 CFR Part 11 Compliant Temperature Data Loggers

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21CFR Part 11 Data Loggers

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Top 5 Data Storage Mistakes Costing Pharma Compliance

If you're a QA/QC manager or operations lead in pharma, your data isn’t just data—it’s compliance evidence. But most teams unknowingly put this critical data at risk.

From temperature logs to audit trails, data is often:

Scattered across USBs, laptops, SD cards

Lost during power outages

Hard to retrieve during audits

These lead to non-compliance, delays, and even product recalls.

Common Pharma Data Challenges:

Scattered Storage: Data spread across multiple devices is hard to validate. Fix: Use cloud-connected data loggers for centralized, traceable storage.

Weak Integrity Controls: Non-compliance with 21 CFR Part 11 and ALCOA+ causes audit failures. Fix: Choose systems with digital signatures and audit trails.

No Real-Time Monitoring: Delayed deviation detection = late action. Fix: Use Wi-Fi/GSM loggers with real-time alerts and dashboards.

Power Outage Data Loss: One failure can erase crucial logs. Fix: Opt for devices with onboard memory and auto-recovery.

Limited Local Storage: Pharma generates too much data. Fix: Shift to scalable cloud-based solutions.

At G-Tek, we help you stay audit-ready with compliant, cloud-enabled, real-time systems. Don’t wait for an audit to expose the problem. Fix it now.