GxP-Compliant Facility Monitoring & Data Integrity

“Compliance Without Compromise”

The Monitoring Challenge

Safeguarding Stability at Scale

Pharmaceutical warehousing requires more than just cooling; it demands absolute environmental control. Large-scale facilities face unique risks, from thermal stratification in high-ceiling racks to “hot spots” near loading docks.

The Regulatory Burden:

Data Integrity: Compliance with 21 CFR Part 11 regarding electronic records and audit trails.
MKT Calculation: The need for automated Mean Kinetic Temperature reporting to assess long-term stability.
Validation Gaps: Ensuring every pallet position stays within validated 15°C to 25°C or 2°C to 8°C ranges.

How The Solution Helps

Audit-Ready Intelligence

G-Tek transforms warehouse monitoring into a centralized, ALCOA+ compliant ecosystem. We eliminate “Audit Anxiety” by ensuring your data is protected, traceable, and instantly accessible.

Key Features:

21 CFR Part 11 Networked Systems: Secure, encrypted data with multi-level access and digital signatures.
Automated Reporting: Instant MKT and excursion summaries eliminate manual spreadsheet errors.
Scalable Infrastructure: Long-range wireless or wired mesh sensors designed for sprawling, high-rack facilities.
Validation Readiness: Comprehensive support for IQ/OQ/PQ processes to accelerate facility qualification.