enVigil–V: Environmental Monitoring System
enVigil V offers a configurable facility monitoring software system aimed at Pharmaceutical, Healthcare, Electronic and Satellite production facilities. enVigil V has evolved from many years of applications with a need to address the regulatory requirements of EU-GMP, cGMP, GAMP and associated standards.
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enVigil V provides a configurable client interface allowing multi-level mimic displays to be configured. This includes alarm indicators, point value tables, conditional text, control buttons, graphic images including jpg, bmp images which can then be animated. Simple point and click access from the on-screen
alarm indicators provides further access to trend, alarm and historic reports. Alarm acknowledgement is available from a pre-configured comments list and/or free text entry by the user.
enVigil–V: Environmental Monitoring System
enVigil V is available with license sizes of 25, 50, 100, 200, 500 and 10,000 Input/Output (I/O) point database allowing data from non-viable particle counters, viable air samplers, environmental sensors and other input/output devices to be configured. Up to 128 individual tasks can run concurrently within the enVigil V application and these can range from individual I/O drivers, SMS text /email communications, auto-archiving, real time calculations, scheduling, batch reporting and ModBus/OPC interfaces
- enVigil V offers support for multiple particle counters, active air samplers and environmental sensors
- Modern dashboard interface gives ability to show high level stats and system parameters
- Server clusters support multiple network clients sharing information
- Cloud connectivity enables data to be sent to third party applications
- SQL Data to third party databases
- Multi-level mimic diagrams
- Trend displays with multiplec ursors
- Reconciled alarm reports with Trend Metrics
- Touch screen clients, Tablets, Alarm message displays and beacons
- Interfaces to external systems via OPC, ModBus and ODBC/SQL database applications
- SMS text and email alerts
- Server/Client architecture with network clients
- Hot standby functionality (optional)
- Batch reporting with electronic signatures
- Installed on Windows, Windows Server and virtual machine Windows OS platforms
The user interface is securely configured with multiple levels of User access: Operator, Supervisor Manager and System Administrator. enVigil V offers data logging to secure log files which cannot be modified, deleted or altered.
21 CFR Part 11
Compliance Assured
Pharmagraph software has been written from the ground up to comply with the tough demands of 21 CFR part 11 through the use of tight security, proprietary binary logging and provision of an audit trail. The software system is secured via unique usernames and passwords, with automatic log out when the system is left idle. A secure binary format is used for data log files making it virtually impossible to alter records. An audit trail logger automatically tracks changes to the system configuration, recording what has been changed, by whom, when and for what reason. The audit trail logger also records operator log in and log out activity, including failed log in attempts.
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