Novatek International

Novatek International

- Environmental Monitoring Management Software

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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.

Our Environmental Monitoring database management and trending solution comes with superior trend features that allow you to analyze your data quickly and efficiently without the time consuming task of transferring to non compliant spreadsheets. Using our flexible filtering feature, group results by room, site, microorganism, person, class, and other criteria to provide documented ‘root cause’ analyses. Use the module’s investigation window in order to conduct a rapid and detailed examination of Out of Specification (OOS) data to quickly determine what measures need to be taken in order to correct and prevent a reoccurrence.

The design of Novatek’s Environmental Monitoring Program© includes everything you need to maximize your day-to-day efficiency. This feature rich software solution even allows you to import your facility maps for viewing to help maintain consistent sampling points over time. Electronic worksheets help you reduce paper consumption and bar coding capabilities provide easy access to the system and streamline data entry. Micro ID images can be stored in the system for future reference. By capture microorganism identification by percentage your validation department can easily perform disinfectant efficacy tests.

An important component of any manufacturing process or production line is the availability of utilities, like water, clean steam, compressed air, that do not adversely impact the quality of the final product. Our Environmental Monitoring software solution makes point of use sampling easy through the utility monitoring feature sets.

The Environmental Monitoring Program© is a complete off-the-shelf solution designed to ensure a ‘state of control’ over your manufacturing environment.

Novatek's imprint in the industry includes continuing education and industry forums by way of educational Seminars and Web Seminars and participation of speakers at various key events including the PDA, IVT, IPA etc. We continue to publish our respective findings and knowledge through different publications such as Jeanne Moldenhauer's book: Environmental Monitoring, Volume II, Part 5, Acquisition and Implementation of an Environmental Monitoring Software Program.

Our Environmental Monitoring Program© is the only software solution on the market today that is capable of capturing, managing, and reporting all environmental data for sterile and non-sterile health care industries. It has been designed for any type of viable/non-viable testing including personnel monitoring and utility monitoring and is based on the latest guidelines from FDA, EU, ISO 14644-1 and PDA Technical report 13. It also provides the visibility and root cause analysis tools that are needed to maintain your facility in complete control, mitigating risk and improving the quality of your products.

Environmental monitoring is a critical process within the pharmaceutical and biotechnology industries. The purpose is to determine the microbial and particulate content of clean room air and surfaces, as well as utilities used in the manufacturing of a product. A well designed protocol (sample plan) highlights conditions contributing to excessive microbial & particulate levels due to ineffective cleaning, or personnel and equipment issues.

Based on the classification specifications of “Alert and Action,” when quality levels are exceeded this may signal a possible deviation from normal operating conditions and may not require action, but may need to be monitored more closely or it may signal an apparent deviation from normal operating conditions and requires immediate action. By adopting a software solution that captures the right data quickly and in real time, proactive management of your site becomes possible.

With our EM software you are able to apply superior trending & statistical analysis of results quickly. Our Environmental Monitoring Program’s extensive filtering capabilities allow you to perform investigations into drifts in trends and OOS results in practically no time. Accurate identification of potential problems will enable your team to pinpoint the root cause of issues as they arise and effect timely solutions. The faster the problem is identified, the more quickly it can be resolved.

One of the keys to a successful environmental monitoring program is being able to be in a ‘state of control’ by being able to continuously evaluate your EM program by having the tools in place to gather measurable and meaningful data as well as “other” supporting data. For example meaningful data, quite simply, would be environmental monitoring sampling plans (protocols), specifications, monitoring results, quarterly reports, etc. They would be supported by related procedures like disinfectant studies, cleaning programs and also personnel training records for aseptic gowning. Our EM software has parameters to capture all of these crucial bits of data. You can’t control what you don’t measure and you can’t get to the root of a problem without the right data!

As you can see having environmental monitoring software that is designed to remediate risk is all about your automation assisting your process controls that you’ve put in place to make production adjustments based on the timely analysis of errors that are detected or process deviations that are found. Using complimentary software can give you the opportunity to act quickly to correct issues while the product is being made. It goes without saying that assessing risk and applying corrective actions is the more cost-efficient approach that will in turn help environmental monitoring software pay for itself!

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