Novatek Environmental Monitoring

Novatek Environmental Monitoring is an industry-proven software solution with over 20 years of use in managing controlled environments for GMP and pharmaceutical facilities. Designed as a true off-the-shelf solution, it has evolved continuously in response to user specifications and regulatory requirements, delivering a powerful and compliant platform to evaluate, manage, and reduce the risks associated with everyday environmental monitoring activities.

The software takes a process-based approach that maps to the entire sampling workflow — controlling the process as a whole rather than simply scheduling individual sampling points. It captures all critical quality control parameters, enforces compliance with standard operating procedures, and facilitates cGMP best practices. This includes seamless integration of the QC laboratory, instrumentation, and mobile sample acquisition in a fully paperless environment.

Key Features

• Paperless process with centralized data and data management
• Batch-related and on-demand scheduling
• Rapid data entry capabilities
• Utilities monitoring
• Viable and non-viable sampling support
• Comprehensive reporting capabilities, including dedicated USP <1116> reporting
• Automated investigation management and root cause analysis
• Facility map feature for visualization of positive counts
• Integration to ERP, LIMS, and other software systems
• Integration to particle counters and air samplers
• Integration to process monitoring and QC lab instrumentation
• 21 CFR Part 11 and Annex 11 compliant

Key Benefits

• Improved operational efficiency, saving time and money
• Powerful risk management tool for establishing and monitoring risk-based environmental monitoring programs
• Risk mitigation through smart monitoring
• Earlier identification of contamination
• Reduced regulatory and business risks
• Enforced GMP and best practices, minimizing critical operator error
• Process-based feedback that assures a state of control
• Real-time data trending and analysis
• Alert and action level excursion management

Facilities Mapping and Excursion Reporting

• Associates both routine and batch-related monitoring to specific sample points on a visual floor plan of the facility
• All positive counts are plotted on maps at the exact sample point, with color coding to clearly indicate the level of positive counts
• Users can filter data by date range, room activity, sample type, microorganism (genus, species, strain, gram stain), personnel, and other sample-related criteria
• Supports importing of room maps from programs such as AutoCAD or drawing tools like Microsoft Visio
• Sampling site locations can be loaded onto the map and monitored visually for any room or area, across any time period

Risk-Based Environmental Monitoring Approach

• Recognized as a market leader for risk-based environmental monitoring programs
• Supports proactive monitoring to recognize problems before they occur, rather than simply reacting to excursions after the fact
• Enables risk scoring of predetermined production areas using tools such as FMEA (Failure Mode and Effects Analysis)
• Real-time trending monitors data for patterns, allowing users to correct problems before they escalate
• Automated investigations and root cause analysis help identify high-risk areas in production and support the risk scoring process
• Particularly suited to critical manufacturing processes such as aseptic filling of sterile products

Novatek Environmental Monitoring integrates with related solutions including a mobile sample acquisition module, water and utility monitoring management software, and cleaning validation tools, making it a comprehensive component of a broader contamination control and quality management ecosystem.