Facility Monitoring Software
Facility Monitoring Software
Pharmagraph enVigil facility monitoring software platforms are purpose-built for particle and environmental monitoring in EU GMP Annex 1, PIC/S PE 009 regulated controlled environments. With over 1,000 Pharmagraph systems now installed worldwide, these platforms are extensively used in pharmaceutical manufacturing, hospitals, nuclear medicine, compounding and in other areas. They have developed from over 35 years of experience delivering EU GMP compliant solutions.
Designed for regulated environments, enVigil platforms provide full oversight of critical parameters including airborne particulates (multiple particle counter brands), differential pressure, temperature, humidity, and airflow. They also support equipment monitoring for fridges, freezers, incubators and other equipment, all within a single, validated platform.
From aseptic filling lines and ATMP cleanrooms to hospital pharmacies and IVF clinics, enVigil systems are deployed worldwide to support compliant, real-time monitoring in high-stakes environments.
At its core, enVigil is built around the latest regulatory standards: EU-GMP Annex 1, cGMP, GAMP, and 21 CFR Part 11. Whether you’re upgrading legacy systems or designing a new facility, we help you move towards compliance and stay there with confidence.
Pharmagraph enVigil PnP
enVigil PnP is a pre-configured environmental monitoring solution designed to simplify deployment, reduce validation effort, and accelerate time to compliance in regulated environments, such as cleanrooms and laboratories.
Built on the proven enVigil platform, enVigil PnP combines validated software, pre-tested hardware and defined system architectures into a ready-to-deploy solution. This approach reduces project complexity while maintaining the robustness required for EU-GMP/GLP regulated applications.
Pharmagraph enVigil IMS
enVigil IMS is designed to support continuous monitoring at the point of manufacture, where isolators, RABS and aseptic processes demand tight control of environmental conditions.
The system integrates particle monitoring, viable sampling, pressure cascades and environmental parameters into a single process-aware architecture. This allows critical conditions to be monitored in context, not as isolated data points, supporting faster investigation, clearer audit trails and more confident decision-making.
Pharmagraph enVigil FMS
enVigil FMS is designed for organisations that need facility-wide monitoring and control across complex, regulated environments. It is ideally suited to sites where environmental performance must be managed consistently across many cleanrooms & controlled environments.
enVigil FMS supports particle counters, environmental sensors, fridges, freezers, incubators and other equipment, helping ensure environmental consistency beyond primary production areas. The result is greater confidence, reduced operational risk, and clearer accountability across the entire site.
Reduce Installation and Validation Effort
Complete with validation documentation, enVigil PnP is a low cost, ready to deploy software platform designed for monitoring a smaller numbers of particle counters and environmental sensors.
By standardising system configuration and documentation upfront, enVigil PnP helps teams:
- Shorten installation timelines
- Streamline qualification activities
- Reduce engineering and validation risk
- Maintain consistency across deployments
Built around EU-GMP Annex 1, cGMP, GAMP and 21 CFR Part 11, enVigil PnP enables compliant monitoring without the complexity of fully bespoke system design.
21 CFR Part 11 Compliance
Pharmagraph software is designed to meet the requirements of 21 CFR Part 11, supporting secure data handling, traceability and system integrity in regulated environments.
Key compliance features include:
- Secure user access with unique logins and automatic logout
- Protected binary data storage to prevent record alteration
- Full audit trails capturing what changed, when, by whom and why
- System and operator activity logging, including failed login attempts
Together, these features support faster validation and confident regulatory inspections.
Process Visibility Across the Isolator Workflow
Within isolator and filling line environments, enVigil IMS enables monitoring across multiple zones and operational states, supporting normal operation, intervention and recovery phases.
Its modular architecture allows IMS to scale with process complexity, integrating sensors, samplers and alarms in line with defined process requirements, while maintaining a consistent data structure for reporting, trending and review.
Designed to align with EU-GMP Annex 1 expectations for continuous monitoring and data integrity, enVigil IMS supports reliable operation throughout the lifecycle of the isolator or production system.
21 CFR Part 11 Compliance
Pharmagraph software is designed to meet the requirements of 21 CFR Part 11, supporting secure data handling, traceability and system integrity in regulated environments.
Key compliance features include:
- Secure user access with unique logins and automatic logout
- Protected binary data storage to prevent record alteration
- Full audit trails capturing what changed, when, by whom and why
- System and operator activity logging, including failed login attempts
Together, these features support faster validation and confident regulatory inspections.
For Cleanrooms & Controlled Environments
enVigil FMS is deployed across pharmaceutical manufacturing facilities, ATMP cleanrooms, hospital pharmacies and life science environments where site-level environmental control and compliance are essential.
By centralising environmental data across rooms, zones and systems, enVigil FMS enables teams to monitor trends, manage alarms and respond to deviations with confidence.
Built around EU-GMP Annex 1, cGMP, GAMP and 21 CFR Part 11, enVigil FMS supports compliant facility monitoring throughout the lifecycle of the building and its critical infrastructure.
By providing a single operational view of environmental conditions across the facility, enVigil FMS helps teams:
- Maintain control across interconnected areas and processes
- Identify trends and deviations early, before they impact compliance
- Coordinate responses across quality, engineering and operations
- Demonstrate ongoing control during audits and inspections
In addition to cleanroom and controlled space monitoring, enVigil FMS supports oversight of critical supporting equipment such as fridges, freezers and incubators, helping ensure environmental consistency beyond primary production areas.
The result is greater confidence, reduced operational risk, and clearer accountability across the entire site.