Novatek’s Environmental Monitoring software is a proven industry standard system with over 20+ years of global use in the Pharmaceutical and Biotech industries. As a true “out-of-the-box” solution, the core of our environmental monitoring solution has evolved in response to years of user specifications and continuous improvement, meeting at least 95% of your requirements while anticipating industry trends. In addition, having the core competency of a true software engineering company, our EM solution’s integration into LIMS, ERP Systems and instrumentation is seamless and fast! Risk-Based Environmental Monitoring involves first assessing high risk areas in production and then building a sampling program around them. 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). Your data is more than just a number. That’s why traditional EM software needs to go beyond current capabilities and provide the tools necessary to support the risk assessment process. Benefits of using Novatek Environmental Monitoring Risk Mitigation Software Solution Include: • Efficiency and automation through a truly paperless system with centralized data • Process-Enforced Compliance: Done through procedural controls enforcing regulatory and procedural best practices • Comprehensive Reporting using real-time data trending (both viable and non-viable) • Insightful Data Management Tools o Visual pattern recognition features o Root-cause analysis capabilities o Reverse traceability search tools o Automated investigation management reporting Novatek’s Environmental Monitoring Management software not only delivers optimum automated monitoring solutions for an organization’s production environment, it also leverages the efficiency and effectiveness of a Total Quality Management System, eliminating paper-based processes and reducing overall production costs.