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Pharmagraph has launched its latest FMS software offering enVigil V. enVigil V systems are deployed specifically for facility and environmental monitoring applications. Evolved from a need to address the requirements of EU-GMP, cGMP, GAMP and associated regulatory standards. enVigil V offers a configurable facility monitoring software system aimed at pharmaceutical and healthcare production including Isolator and RABS Filling Lines.

Enhancements to the previous enVigil-FMS software version focus on providing additional features to address virtual machine deployment and filling line applications. enVigil V offers capability for multiple servers to connect to distributed network view nodes in a network cluster. Aimed at the increased deployment of enVigil systems running on a server and virtual machine platforms, the network cluster offers unrivaled oversight of the monitoring system installations.

Multiple filling suites can be managed through individual enVigil V server applications running a self- contained monitoring system for each line. This enables system deployment to be easily achieved in terms of commissioning, verification and validation without interruption to existing filling suites. The network cluster topology enables personnel from production, engineering and quality control to have easy oversight of each filling suite. Coupled with the enVigil V dashboard mimic it provides meaningful information about production performance, alarm management, batch reporting/ sign off and any failure investigations that may be required.

enVigil V offers advanced cubic meter particle monitoring to reduce system down times by offering an “Out of Compliance Predictor” and “Cubic Meter Event Monitoring” for the non-viable particle counting element of the filling line application. The Out of Compliance Predictor enables filling line systems to predict out of compliance operation and offers corrective action to be taken before alarm conditions occur, thereby avoiding investigations, write ups and prolonged system down times.

The Cubic Meter Event Monitoring application allows out of compliance events to be corrected, acknowledged and cleared as soon as the system is back in a compliant state. It allows cubic meter alarm status to be cleared once satisfactory operating conditions are re-established, typically within a few minutes. The clearance of the cubic meter alarm status is enabled once the system returns to a compliant state with the clearance being executed by a suitably privileged user (Supervisor or Manager), which is audit logged accordingly.

The enVigil V software also includes an instrument tracking facility. This enables both production and QC personnel to know which instruments (non-viable and viable particle counters) were used in which sampling positions. If there are any production related issues involving the particle monitoring system, then the instrument tracking facility can assist in the identification and root-cause investigation of any instrument failings.