The Novatek Environmental Monitoring Software Solution, Nova-EM, is an industry proven standard with over 15 years of industry use, for managing controlled environments. As a true “Off the Shelf” solution, the core of Nova-EM software has evolved in response to years of user specifications, and regulatory requirements, through a continuous improvement process. The result is a powerful and compliant solution, designed to evaluate, manage, and reduce the risks associated with Environmental Monitoring.
Nova-EM is a process based solution that maps to your entire sampling workflow. The software controls the process as a whole, not just scheduling for individual sampling points, but also capturing all critical quality control parameters. By enforcing compliance with standard operating procedures Nova-EM facilitates cGMP and following best practices. This includes the integration of the QC Laboratory, instrumentation and mobile sample acquisition in a paperless environment.
NOVA-EM KEY FEATURES:
- Paperless process with centralized data & data management
- Batch Related & on-demand scheduling
- Rapid data entry
- Utilities Monitoring
- Viable and Non-viable sampling
- Comprehensive reporting capabilities
- Automated investigation management & root cause analysis
- Facility map feature for Visualization of positive counts
- Integration to ERP, LIMS & other software
- Integration to Particle Counters and Air Samplers
- Integration to process monitoring & QC lab instrumentation
- 21 CFR Part 11 Compliant / Annex 11 Compliant
- Dedicated USP <1116> Reporting
NOVA-EM KEY BENEFITS:
- Improved operational efficiency saving time & money
- Powerful risk management tool for establishing & monitoring a risk based Environmental Monitoring programs
- Risk mitigation through Smart Monitoring
- Identify contamination sooner
- Reduced regulatory & business risks
- Enforced GMP & Best Practice minimizing critical operator error
- Processed-Based Feedback Assures “State of Control”
- Real time data trending & analysis
- Alert and action level excursion management
NOVA-EM: FACILITIES MAPPING / EXCURSION REPORTING
Nova-EM’s Visual Facility Control Tool associates both routine, and batch related monitoring, to specific sample points on a visual floor plan of your facility. All positive counts are plotted on the maps representing the controlled areas at the exact sample point. Color coding clearly indicates to the user the level of the positive counts. Users can filter to include data, filter criteria includes date range, room activity, sample type, or microorganism (Genus, Species, Strain, Gram Stain), personnel, and other sample related data.
Nova-EM allows for the importing of room maps from programs like AutoCAD® or via a drawing tool like Microsoft Visio. Sampling site locations can then be loaded onto the map and monitored visually for any room/area, for any time period.
NOVA-EM A RISK BASED APPROACH | “YOUR DATA IS MORE THAN JUST A NUMBER”
The Nova-EM solution is the market leader for Risk Based Environmental Monitoring programs. With global regulatory pressure increasing, pharmaceutical companies must prove that their processes are under control, and that measures are in place to correct a problem should it happen. Simply addressing an excursion in a reactive way is not enough as the production has continued and the product is already at risk. There is a need for proactive Environmental Monitoring programs to recognize problems before they happen. This has resulted in a shift in thinking toward a “Risk-Based” approach for the monitoring of critical manufacturing processes such as aseptic filling of sterile product.
Risk-Based Environmental Monitoring involves first assessing high risk areas in production then builds a sampling program around it. In order to do this you must first be able to score the level of risk in predetermined areas of production with tools like FMEA (Failure Mode & Effects Analysis). Nova-EM contains powerful tools such as real-time trending, automated investigations and root cause analysis which help to identify high risk areas in production and to aid in the risk scoring process. The in depth analysis will help you to understand why these areas are at risk. Nova-EM’s real-time trending will monitor data for patterns, allowing you to correct a problem before it occurs.