The pharmaceutical industry faces unique regulatory requirements regarding environmental monitoring
EU GMP Annexes 1 and 11 require continuous monitoring of cold rooms, cleanrooms, and storage areas. Conventional data loggers do not transmit data in real time—a missed alarm at night can invalidate an entire batch.
Monitoring data must be immutable, time-stamped, traceable, and accessible for audit purposes. Spreadsheets and manual logs do not meet the data integrity requirements of EU GMP and the FDA.
Incubators, freeze-dryers, autoclaves, pharmaceutical refrigerators, laminar flow hoods: each piece of equipment has its own proprietary protocol or RS-232/RS-485 serial interface. Integration is complex without a universal gateway.
A temperature fluctuation in a cold storage room must trigger an alert within 5 minutes. Existing monitoring systems check for changes every 15 minutes—too slow to prevent inventory losses.
R&D labs, production plants, logistics warehouses, and subsidiaries: Consolidating monitoring data from 5 to 50 sites into a single dashboard is a major technical and organizational challenge.
Cleanroom control systems are not inherently secure. Unsecured remote access (standard VPN) exposes your critical pharmaceutical equipment. NIS2 addresses this regulatory risk.
Each feature meets a specific regulatory requirement
Multi-sensor data acquisition (PT100, thermocouple, HVAC sensor) for up to 32 points per gateway. Resolution: 0.1°C. NTP/GPS time stamping.
Direct connection to industrial data loggers, HVAC controllers, and particle monitors. No adapter is required for Modbus devices.
Detects out-of-range conditions and sends an SMS/email/webhook alert in less than 60 seconds. Automatically escalates if not acknowledged within 5 minutes.
Each data point is time-stamped, cryptographically signed, and stored along with its context (sensor ID, calibration, operator). The data is unalterable and Annex 11-compliant.
A consolidated view of all your production and storage sites. Real-time status for each area, 10-year history, and PDF exports for audits.
Remote access to SCADA systems and PLCs without an open inbound port. Outbound-only OpenVPN. Comprehensive access logs for FDA/EMA audits.
Automatic generation of temperature validation reports (IQ/OQ/PQ), mapping studies, and deviation reports. PDF or CSV format.
Binders, Memmert, BEKO, Thermo Fisher, Julabo, Climatic cabinets: native integration or via adapters. Compatibility list available upon request.
From the laboratory to logistics: all pharmaceutical areas monitored in a single system
Eziwan is designed to meet the requirements of major pharmaceutical regulations
Data integrity, audit trail, computerized systems. Non-modifiable data with verifiable timestamps.
New text, Annex 1: Continuous monitoring of aseptic areas, CCS (Contamination Control Strategy).
Electronic signatures, complete audit trail, role-based access. Compatible with sites that export to the United States.
Temperature traceability throughout the supply chain. Records available for EMA/ANSM inspection.
Medical devices: management of storage conditions, process traceability, and control of measuring equipment.
Critical pharmaceutical sites are essential NIS2 entities. Eziwan provides the required audit log and access control.
Note on validation: Eziwan provides a comprehensive Supplier Qualification File (SQF) that includes functional and technical specifications, a requirements traceability matrix, and reference qualification protocols. Our team supports your QA teams throughout the IQ/OQ/PQ process. Contact our pharmaceutical expert.
Demonstration tailored to your specific use case. Our pharmaceutical expert will work with you to assess the applicable regulatory requirements and determine the appropriate monitoring architecture.