Software

 

Software

Pharmagraph publish the enVigil software suite which is deployed specifically for facility and environmental monitoring applications. With a pedigree that has been derived from thirty years’ experience in providing EU-GMP compliant monitoring solutions, the enVigil software range offers an EU-GMP/GLP compliant monitoring system for a range of applications. From pharmaceutical cleanrooms to satellite manufacturing facilities, Pharmagraph’s enVigil systems are deployed worldwide to measure environmental parameters such as airborne particulates, differential pressure, temperature, humidity and air flow. These systems may also be expanded to include equipment monitoring of fridges, freezers and incubators. The monitored facilities range from pharmaceutical aseptic filling suites, stem cell/ATMP facilities, IVF clinics, hospital pharmacies, blood banks, cold chain storage suites and satellite manufacturing facilities.

At the heart of the enVigil suite of software is the adherence to the requirements of the EU-GMP Annex 1, cGMP, GAMP and 21 CFR Part 11 thereby ensuring the installed system can meet current regulatory requirements.

Building blocks for compliance

The enVigil suite of software is provided in three variants:

enVigil–V FMS: Environmental Monitoring System

enVigil V offers a configurable environmental 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.

  • 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 multiple cursors
  • 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 10, Windows Server and virtual machine Windows OS platforms

enVigil V is available as both development and runtime licenses with license sizes of 25, 50, 100, 200, 500 and 10,000 Input/ Output (I/O) point database. 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

Download the full enVigil V Brochure here to find out more.

enVigil-IMS Brochure download

enVigil-V Brochure download

enVigil V screen cluster
Standard and medical tablet deployment

Standard and medical tablet deployment


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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Head Office
Pharmagraph
39 Ivanhoe Road, Hogwood Industrial Estate
Finchampstead, Berkshire, UK
RG40 4QQ
Contact
Tel: +44 (0) 1252 861700

email: sales@pharmagraph.co.uk
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Pharmagraph is a division of Acquisition Systems Ltd. © 2020 Acquisition Systems Ltd  |  Registered in England No. 2429137  |  Registered Office: 39 Ivanhoe Road, Hogwood Industrial Estate, Finchampstead, Berkshire, RG40 4QQ