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Ensuring compliance with regulatory requirements is a foundational commitment for manufacturers operating in GMP-adhering industries.

Ensuring regulatory compliance is a cornerstone commitment for manufacturers in GMP-adhering industries. Deviations with environmental conditions can lead to costly product recalls, regulatory non-compliance, and ultimately, compromised quality.

Environmental Monitoring Systems (EMS), also known as Critical Monitoring Systems (CMS), actively support compliance through real-time monitoring and recording of crucial parameters and actions. An EMS empowers businesses to proactively identify and address potential issues before they escalate.

This proactive approach not only prevents regulatory penalties but also enables the identification of trends and potential risks, ultimately safeguarding product quality and enhancing operational efficiency.

Benefits of an Environmental Monitoring System

Far beyond mere surveillance, EMS systems excel in real-time monitoring, root cause identification, and documentation and compliance in tracking environmental conditions for your facility and equipment:

  1. Connectivity to All Critical Parameters

While Building Management Systems might seem like a convenient source of environmental data, they fall short when it comes to true compliance-grade environmental monitoring. Unlike the flexible and agnostic approach of an EMS, BMS systems are often limited in their sensor compatibility and data connectivity. They struggle to integrate with built-for-purpose sensors crucial for gathering real-time data on critical parameters like temperature, humidity, and pressure.

This lack of specialized sensor connectivity often leads to compliance challenges, as BMS data alone may not be sufficient for complete regulatory oversight. In contrast, an EMS provides a robust and flexible solution. Its software and sensor agnosticism allow you to easily add sensors and connect to other vital business systems like LIMS and Clean Rooms, creating a comprehensive and compliant environmental monitoring ecosystem.

Don't settle for the limitations of a BMS - choose an EMS that empowers you to connect to all critical parameters and achieve true environmental compliance.

  1. Real-time Monitoring and Alarm Notification:

By constantly watching critical parameters, an EMS instantly alerts you to any deviation from pre-set boundaries. Potential issues are identified promptly, allowing for immediate corrective action before they turn into product quality disasters. This early detection minimizes the impact of the deviation, preventing the production of non-compliant batches and ensuring your final product remains viable.

  1. Enabling GMP Compliance

An EMS facilitates GMP compliance through comprehensive data capture and auditable trails. Every alarm event and environmental parameter are meticulously logged with timestamps, providing an irrefutable record of compliant production and product storage conditions. User actions are also meticulously tracked, with usernames, descriptions of activities, and timestamps recorded at the time of action.

This data resides securely in a hardened SQL Server database and is accessible through reports for detailed analysis of audit trails, alarms, and user activity. This robust system provides irrefutable evidence of compliance throughout the production and storage lifecycle, safeguarding product quality, safety, and efficacy.

  1. Streamlined Deviation & CAPA Processes:

By capturing precise timestamps for every alarm event, from its occurrence to acknowledgement and return to normal, the EMS streamlines deviation and CAPA processes. This meticulous recordkeeping, crucial for both compliance and quality assurance, enables effective tracking and analysis of environmental conditions over time. Furthermore, the system allows associating corrective actions directly with specific alarms, creating a self-documented record of compliance.

  1. Simplifying Sensor Calibration and Documentation:

Our EMS platform streamlines the process of cumbersome calibration, letting you handle single or two-point calibrations directly through a secure HMI interface. No more diving into complex control systems like BMS or PLCs. The changes are self-documenting, eliminating mountains of paperwork and drastically reducing the effort needed for periodic calibration and associated change control.

Explore More: View Our CMS/EMS Demo

Our Critical Monitoring System (CMS) / Environmental Monitoring System (EMS) solution enables rapid development and regulatory compliance for leading life sciences manufacturers.

 

 

Features of Environmental Monitor Systems

A robust EMS platform comprises a software solution with built-in functionality designed to accelerate the establishment of an effective environmental monitoring infrastructure with GxP-compliant features built in. Key features include:

  1. Out-of-the-Box Connectivity:

Seamlessly connect with Building Management Systems (BMS) through BACNet or industrial data sources such as PLC, OPC UA, and MQTT. This ensures compatibility with existing infrastructure, reducing implementation time and costs.

  1. Alarm/Event System:

Implement a comprehensive alarm and event system that provides real-time notifications, allowing organizations to respond swiftly to deviations and prevents incidents.

  1. Process Historian:

Capture and store historical data to analyze trends and patterns over time. The process historian functionality facilitates data-driven decision-making and long-term management strategies.

  1. Integration into Existing Security Posture:

Integrate the EMS seamlessly into your organization's existing security posture. This ensures that environmental monitoring aligns with broader security measures, enhancing overall risk management.

  1. Built-in Audit Log:

The inclusion of a built-in audit log ensures that all actions within the EMS platform are recorded. This feature is vital for compliance purposes and reinforces the credibility of the environmental monitoring data.

Begin Your Journey with an Automated Environmental Monitoring System

Leading with our client-first approach for over 20 years, we’ve helped hundreds of leading manufacturers and industrial automation companies transform and optimize their processes. Are You Ready to Get Started with EMS and CMS?