Novatek is the established market leader for environmental monitoring data management and trending software. The Environmental Monitoring Program is a comprehensive software solution that is continuously innovated to capture the ever growing needs and industry standards of the Pharmaceutical, Biotech, Medical Device, Tissue Bank and other Health Care industries.

Quality by Design

Quality by Design is a philosophy that refines the level of knowledge associated with a process then uses process understanding to deliver a product with the desired critical quality attributes. Quality cannot be tested into products; it should be built-in. This is how it is with Novatek’s Environmental Monitoring Program software. The designers of the Environmental Monitoring Program applied their in-depth knowledge of EM factors affecting batch integrity thus building into their design space the functionality to allow critical quality attributes to be monitored. The outcome is software that clearly demonstrates to users across the globe input variables and process parameters to provide assurance of quality. This translates to product lots that will meet established quality standards for release and shelf life with very few or no product failures or defects.

:: top ::

Figure 1: Quality by design ensures process control.

:: top ::

A Pro-Active Tool for Quality Assurance

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.

:: top ::

Industry Imprint

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.

"As a past Director of Manufacturing for Wyeth Vaccines in Sanford, NC, I am aware of the critical need to implement an automated environmental monitoring system in order to meet the regulatory requirements for tracking and trending of environmental monitoring data. Novatek's Environmental Monitoring Program software solution brings timely and innovative automated solutions to addressing this critical industry challenge. The EM program helps companies meet FDA and other regulatory agency expectations and is very user friendly and intuitive in the manner data is presented. As President of an international consulting company, I have had positive success in assisting clients in solving environmental monitoring problems through the implementation of Novatek's EM program.”
- Dr. Frank S. Kohn, President, FSK Associates Inc.

:: top ::

Protocol building

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.

Figure 2: Environmental Monitoring Protocol window showing a dynamic (in-production) sampling plan for an ISO 5 filling room. Tests included are microbial (air and settle plate and swabbing), non-viable (particulate counts) and personnel monitoring (finger dabs and gowning).

:: top ::

Capture Results

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.

Figure 3: Environmental Monitoring Program Summary of results window showing immediate visual color coded notification of “Out-of Specification” results based on specifications for alert and action levels.

Figure 4: Start an investigation directly within the EM software.

:: top ::

Trend Results

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. Then corrective and preventative actions can be put in place to improve on your EM process.

Figure 5: The trend selection window offers greater flexibility in the trends generated. Options in this window include a trending by grouping ID code, group, building, test type, room, microbiologist, microorganism, genus and location.

Figure 6: Using the filter feature, data trended may be filtered and ordered by appropriate fields such as building, classification, department, genus, gram strain, location, plant, room, sample site, summary date, summary state and test type. Frequent filters can be saved and loaded thus making for speedy access to your data when you need it.

:: top ::

Charts and Reports

Figure 7: % of Micro-organisms found

Figure 8: Normal distribution chart

Figure 9: Excursion Report

Figure 10: Bar chart

:: top ::

Root Cause Analysis

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!

:: top ::

Risk Based Approach

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!

:: top ::

Our Clients

The Environmental Monitoring Program© application’s underlying structure and foundation have effectively endured the ‘test of time’ with several systems installed, in several countries, around the globe. In fact our Environmental Monitoring Program© application is the only such system installed in six continents and supported locally throughout Asia, Africa, Europe, North and South America, and Australia. What’s more all Novatek software can be provided in multiple languages ensuring full customer satisfaction.

Here’s a sampling of the Environmental Monitoring Program© installations over the last 5 years.

Lifecore • Pfizer • ID BioMed • Hollister-Stier • Groupe Parima • Chesapeake Biologics • Remedica • Ivax
Leo Pharma • Delta Pharma • Monsanto • Bavarian Nordic • Cel-Sci • Lonza • LifeNet • Intercell
Wyeth Forth Dodge • DSM Pharmaceutical • Althea • Medtronic • QSV Biologics • Macroflux • Abbott Vascular
Sicor • UMBI • Genprobe • BMS • Hospira • Hikma • Celltrion • Avant Immunotherapeutics

:: top ::