Real-Time Room and Equipment Monitoring Software to Manage Multiple Locations and Parameters

elproMONITOR is a GxP- and FDA-compliant monitoring software solution developed by ELPRO. It is designed for continuous monitoring of environmental parameters in regulated environments such as laboratories, cleanrooms, cold storage facilities, pharmacies, or pharmaceutical logistics.

The system continuously records, displays, alarms, documents, and archives physical measurements such as temperature, humidity, differential pressure, CO₂, and more—in real time.

elproMONITOR supports all wired and wireless modules from the ECOLOG-PRO series:

Communication modules

• ECOLOG-PRO NBR (for wired measurement modules)
• ECOLOG-PRO RBR (for wireless modules)

A wide range of measurement modules, here are a few examples:

• Wired:
  • ECOLOG-PRO 4PT: 4 inputs for external temperature sensors
  • ECOLOG-PRO 2TH: 2 inputs for combined temperature and relative humidity sensors
  • ECOLOG-PRO 4MA: 4 inputs for 4-20 mA signals (e.g. for CO2, particle counters or differential pressure)
• Wireless:
  • ECOLOG-PRO 1NTR: Wireless NTC temperature module
  • ECOLOG-PRO 1THR: External 3-pin combination sensor for temperature and relative humidity
  • ECOLOG-PRO 4MAR: 4 inputs for 4-20 mA signals (e.g. for CO2, particle counters or differential pressure)

Yes. elproMONITOR is fully compliant with:

• FDA 21 CFR Part 11 (electronic signatures and records)
• EU Annex 11
• GAMP® 5 guidelines (Good Automated Manufacturing Practice)
• Features include audit trail, user role management, electronic signatures, and GMP-compliant alarm handling.

elproMONITOR offers comprehensive alarm functionality:

• Real-time limit value monitoring
• Multi-level alarms via email, SMS, or visual/acoustic signal
• Alarm display in the software dashboard
• Configurable delays, hysteresis, and alarm groups
• Complete alarm logging via audit trail
• Acknowledgment with electronic signature
• Optional: escalation logic and alarm forwarding

Yes, elproMONITOR supports hybrid system architecture, allowing simultaneous use of wired modules via ECOLOG-PRO NBR and wireless modules via ECOLOG-PRO RBR. This enables flexible installation even in complex or existing buildings.

Yes. The elproUSER module provides detailed role- and user-based access control:

• Role-based permissions (e.g. Admin, QA, Maintenance)
• Password policies and account lockout settings
• Electronic signature support for user actions
• Full logging of user activities in the audit trail

Yes. elproMONITOR includes powerful data export and reporting features:

• Automated reports: daily, weekly, or monthly
• Data export in formats like CSV, PDF, Excel, or XML
• System integration via API or direct database access
• Reports can be digitally signed and are GMP-compliant
  
  

The software can be deployed in various environments:

• On-premise installation on a local Windows server or PC
• Virtual machines (e.g. VMware, Hyper-V)
• Cloud or hosted setups for centralized monitoring

Yes. ELPRO provides full validation documentation and services:

• IQ/OQ documentation (Installation & Operational Qualification)
• Ready-to-use templates, test plans, and checklists
• Optional: on-site validation support by qualified professionals
• Help with developing a risk-based validation strategy in accordance with GAMP® 5

ECOLOG-PRO sensors from ELPRO should typically be calibrated once a year to ensure accurate and reliable measurements. However, the exact calibration interval may depend on your internal quality requirements, the application (e.g. GxP compliance), and regulatory guidelines. For critical environments, more frequent calibration might be necessary.

ELPRO also offers calibration services and reminders as part of their support to help you stay compliant.

Yes. ELPRO's room monitoring system can be easily expanded. Whether you use wired or wireless modules, the system is infinitely scalable. You can add new measuring points at any time.

• With the wireless solution, an ECOLOG PRO RBR radio bridge supports up to 50 wireless modules. You can add additional ECOLOG-PRO RBR communication modules at any time.
• With the wired solution, up to 32 measurement modules can be connected to elproMONITOR via an ECOLOG-PRO NBR communication module.
• If you want to record additional parameters, simply add a suitable new measuring module.

Yes, ELPRO can make recommendations on placement.

ELPRO bases its recommendations on international guidelines such as EU-GMP, Annex 1 & 11, WHO TRS 961, Annex 9, FDA 21 CFR Part 11, and ISPE Good Practice Guides. This is usually based on temperature mapping of the room or device. Based on this data, critical zones (hot/cold spots) are identified, the number of sensors required is determined, and their optimal placement in accordance with regulations is established.

The recommendations are documented in a comprehensible manner so that they can be used as evidence during audits or inspections by authorities.

If you would like to have a professional site analysis or mapping study carried out, ELPRO can provide this as a service.