Is your Contamination Control Strategy (CCS) aligned with Annex 1 of the GMP guidelines?
Published on 18/09/2025
The revision of Annex 1 of the Good Manufacturing Practices (GMP) guidelines requires the implementation of a Contamination Control Strategy (CCS)… The challenge then lies in demonstrating that it is actually effective. It is therefore imperative to establish an Environmental Monitoring System (EMS) capable of providing information and early warnings in response to the continuous collection of large volumes of data.
To support you in implementing your EMS, SYNEXIN has signed a new partnership with Pharmagraph, the global leader in data acquisition solutions for cleanrooms.
The benefits of enVigil:
- SEAMLESS INTEGRATION: Instruments, SCADA, MES, BMS
- INTUITIVE DASHBOARDS: Real-time and historical data
- PREDICTIVE ANALYTICS: Early alerts and assured compliance
- SCALABLE SOLUTIONS: From laboratory to multi-site facilities