Pharmaceutical Monitoring and 21 CFR Part 11 Compliance
GxP-ready temperature and humidity monitoring for pharmaceutical storage. LoggerFlex IoT loggers deliver NIST-traceable data, alarms and audit-ready logs.
From manufacturing to the patient's hands, LoggerFlex ensures quality control across the pharmaceutical cold chain. EDGE Pharma devices deliver NIST-traceable temperature and humidity monitoring with FDA 21 CFR Part 11 readiness, real-time alarms and tamper-proof audit logs — all hosted in a Canadian cloud and trusted by organizations including Novo Nordisk.
Vaccine and cold-storage monitoring
EDGE Pharma WiFi and Cellular models monitor vaccine fridges, freezers and stability chambers with ±0.5°C accuracy and dedicated vaccine-storage profiles. Built-in global cellular keeps reporting even during WiFi or power disruptions, and the patented up-to-3-year battery on 4 AA batteries means continuous coverage of high-value inventory without routine battery service.
FDA 21 CFR Part 11 and GxP records
Every device ships with NIST-traceable calibration and automated certificate tracking, with digital certificates linked to each sensor serial number. Tamper-proof audit logs record every alert and action, and electronic records and signatures support FDA 21 CFR Part 11 and GxP workflows — so monitoring evidence holds up under regulatory inspection.
Real-time alarms that protect inventory
A four-level alarm system escalates by phone, SMS and email the instant temperature drifts out of range, reaching responsible staff in their own time zone across 170+ countries via eSIM. Acting before an excursion turns into a deviation protects both patient safety and the value of vaccines, biologics and temperature-sensitive medicines.
Canadian data residency, audit-ready reporting
All monitoring data resides in Canada with daily backups and redundancy. Generate customizable compliance and MKT reports on demand, complete with calibration traceability, so an inspection becomes a structured export rather than a manual reconstruction. The same LF Cloud platform scales from a single pharmacy fridge to a multi-site network.
LoggerFlex Smart Devices Ltd., headquartered in Canada, manufactures WiFi and cellular IoT data loggers for temperature, humidity, CO₂, pressure, current, and water metering. A patented algorithm delivers up to 3 years of battery life on 4 AA batteries, with real-time alarms and cloud-based data acquisition — no gateway required.