Novatek - Products - Environmental Monitoring Program

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.
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.
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.
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.
Charts and Reports

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!

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