Environmental Monitoring Systems
Know you need an Environmental Monitoring System (EMS)? Unsure where to start? RoviSys delivers proven, turn-key GMP solutions.
An Environmental Monitoring System (EMS) is a comprehensive framework for monitoring and controlling environmental conditions in pharmaceutical or biotechnology manufacturing facilities. EMS ensures the quality and safety of products, especially those subject to regulatory oversight, such as drugs and biologics.
A well-designed and functional Environmental Monitoring System (EMS) provides numerous benefits to pharma, biotech, and biopharma manufacturing facilities.
Key advantages:
• Quality Assurance - monitoring and controlling critical environmental parameters, including temperature, humidity, particle counts, air pressure differentials, and microbial contamination.
• Compliance - Adherence to 21 CFR Part 211 and Part 11, and similar regulations globally.
• Risk Mitigation - Identify and mitigate environmental risk factors to ensure that final products are safe and effective.
• Process Control - Real-time data and alerts when environmental conditions deviate from defined limits, enabling timely corrective actions.
• Product Consistency - Ensure product consistency, reduce batch-to-batch variability.
Services & Deliverables
Benefits of an EMS
• Elevate Operational Efficiency
• Achieve GMP Compliance
• Control Quality through Continuous Monitoring
• Capture Real-time Critical Parameter Data
• Capture Historical Critical Parameter Data
• Optimize Your Process
RoviSys EMS Package Deliverables
• Turn-key Procurement & Installation
• System Impact Assessment
• User Requirements Specification
• Functional Specification
• Design Specification
• Validation Plan
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Risk Assessment
• Data Integrity Assessment
• Standard Operating Procedures
• Validation Summary Report
• Periodic Review Documentation
Project Spotlight
Answering the call from a leading biopharmaceutical company dedicated to transforming patients’ lives, RoviSys delivered a robust environmental monitoring system (EMS) for a state-of-the-art greenfield facility.
The turn-key solution spans clinical manufacturing, QC, and R&D operations, and bolsters reliability and consistency for mission-critical processes. By meticulously overseeing vital environmental parameters— temperature, humidity, particle counts, air pressure differentials, and microbial contamination, the EMS ensures uncompromised quality assurance. Compliant with 21 CFR Part 11, it actively mitigates environmental risks, facilitates real-time process control, and sustains product consistency by minimizing batch-to-batch variability.
