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.
The enVigil suite of software is provided in three variants:
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 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
enVigil V Brochure download
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.