Passive and Active Sample Management EM, Paperless QC & Data Trending

Environmental Monitoring for your Microbiology QC

All-encompassing EM Software for Passive and Active Sample management. A fully paperless environment for your Microbiology QC. We also Integrate your Active samplers to have all the contamination data in one software with all the trending and fully compliant to Annex 1. With over 20 years of industry use, for managing controlled environments, the core of our software has evolved in response to years of microbiology user specifications. A true “Off the Shelf” solution.

Used in Sterile and non-Sterile manufacturing, the software controls the process, not just scheduling for individual sampling points, but also capturing all critical quality control parameters. By enforcing compliance with standard operating procedures, it facilitates cGMP and following best practices. This includes the integration of the QC Laboratory, instrumentation and mobile sample acquisition in a paperless environment.

Novatek environmental monitoring: facilities mapping / excursion reporting

Novatek’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.

Novatek Environmental Monitoring 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.

A risk-based approach | “your data is more than just a number”

Novatek’s software 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). Novatek’s Environmental Monitoring 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. Our real-time trending will monitor data for patterns, allowing you to correct a problem before it occurs.

RISKS:

• Increased risk of contamination without proper state of
  control through trending
• Inconclusive investigations
• Missed adverse trends
• Correction versus prevention

Novatek BENEFITS:

•  Real-time trending and correlation of criteria
•  Identify problem areas before they happen
•  Visibility & State of control
•  Root Cause and pattern analysis to trace the source of contamination
•  Mitigate process risk