The Monitoring Challenge
Navigating the Audit Minefield
In a 21 CFR Part 11 environment, “if it isn’t documented correctly, it didn’t happen.” Manual data consolidation and non-compliant software are the leading causes of 483 warning letters and failed audits. Without automated thermal mapping, identifying “cold spots” in autoclaves or warehouses becomes a high-risk guessing game.
The Compliance Risks:
- Data Integrity Gaps: Missing audit trails or lack of electronic signatures during mapping cycles.
- Complex Calculations: High margin of error when manually calculating $F_0$, $F_h$, or MKT (Mean Kinetic Temperature).
- Validation Delays: Spending days consolidating data from multiple loggers into a single compliant report.
How The Solution Helps
Audit-Ready in One Click
G-Tek provides a tripartite ecosystem designed to automate the entire validation lifecycle.
Product Focus:
- High-Speed Validation Scanners: Rapid multi-point data acquisition for real-time thermal analysis of large-scale equipment.
- Advanced T+RH Data Loggers: Precision sensors for stability chambers and warehouse mapping.
- Paperless Recorders: Digital visualization for continuous monitoring with battery-backed safety.
- 21 CFR Part 11 Software: Integrated software that instantly generates $F_0/F_h$ values, Hold Time reports, and MKT analysis with secure electronic signatures and tamper-proof audit trails.
Products
Relevant Products
Products
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