Environmental Monitoring (EMS)
Annex 1 underlines the need for a Contamination Control Strategy (CCS), and the Environmental Monitoring System (EMS) constitutes the feedback loop that indicates, for controlled zones (cleanrooms and clean enclosures), the effectiveness of that CCS.​
The EMS must effectively monitor and minimise contamination using a risk-based approach, with justification of the adequacy of the programme. Particular importance must be given to trend analysis and continuous improvement.
Given the continuous collection of large volumes of data, an EMS capable of providing information and early warnings is essential.
EMS: a challenge for manufacturers
It must be acknowledged that in most industrial sites, teams are familiar with EMS — yet most systems are under-equipped to meet current Good Manufacturing Practices (GMP) requirements.
When data is not centralised, teams lose time searching for and diagnosing information, or fail to detect deviations early enough, exposing sites to non-conformities during audits and high remediation costs.
This fragmented monitoring enforces a reactive culture rather than a preventive approach to quality.
SYNEXIN supports you in implementing the enVigil solution from its partner Pharmagraph — an EMS that adapts to all operating systems, enables real-time control and visibility with validation at every monitoring stage, and evolves in line with your needs.
The enVigil solution
Through its partner Pharmagraph, SYNEXIN offers you the enVigil solution:
- For cleanrooms and clean enclosures (isolators, RABS), expandable to laboratories, warehouses and cold rooms
- Real-time visualisation and alarms, long-term analysis for trend monitoring, diagnostics and continuous improvement
- Fully supports your compliance with Annex 1 and your Contamination Control Strategy
Discover the advantages of this solution:
| Features | Benefits |
| Continuous multi-parameter monitoring | > Full traceability |
| Smart alarms | > Early detection of deviations |
| TrendMetrics®: trend analysis | > Data-driven improvement |
| Modular and scalable architecture | > Adapts to your site |
Compliance & features
The enVigil solution is compliant from the moment of implementation:
- Developed in accordance with GAMP 5 with a robust qualification package
- TrendMetrics®, the result of over 10 years of development, provides advanced trend monitoring, drift detection and a long-term view of processes
- Alarm management expertise: the right information, to the right person, at the right time — avoiding alert overload and maintaining focus on what matters
- Full compliance with EU GMP Annex 11 and 21 CFR Part 11: electronic signatures and audit trails
- ALCOA+ principles integrated at every level
It offers real-time control and visibility:
- Ergonomic interface: clear display, contextual widgets, minimal training required
- Intelligent algorithms: prioritise and synthesise data to present only relevant information
- Personalised views according to user profile (QA, engineering, operators)
It enables validation and support throughout the lifecycle:
- Supplied with a complete IQ/OQ documentation package
- Lifecycle services: requalification, support and maintenance
One solution, 3 application versions
Whatever your needs, we have a solution to meet them — and it will easily adapt to the evolution of your processes!
Discover enVigil on video​
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