Pharmagraph has been developing Facility Monitoring Software for over 20 years and now has three variants in its enVigil family all of which are 21 CFR part 11 compliant:

 

enVigil FMS: Totally configurable Facility Monitoring System with bespoke validation documentation.

enVigil Lite: ‘Click-To-Configure’ software, supporting MetOne Ethernet based particle counters and Pharmagraph Series 2000 I/O.

enVigil PnP: ‘Click-To-Configure’ software supporting MetOne Ethernet or Serial particle counters, Pharmagraph Series 2000 I/O and Microbiological Air Samplers.

Monitor, Alarm, Log & Report

Supporting serial or Ethernet particle counters, microbiological sampling and environmental measurements, enVigil PnP helps you maintain compliance with minimal effort. Offering a clear status overview with one click access to trends, concise alarm reports and data export to Microsoft Excel™, enVigil PnP delivers the information you need to maintain compliance without tedious configuration and documentation.

• Configures a compliant monitoring system in minutes
• Up to 20 particle counting locations
• Up to 20 environmental locations
• Up to 96 microbiological air sampling locations
• Secure operation using Windows user names and passwords
• Offers trends, alarm reports and XML data export to Microsoft Excel
• Supports remote network clients (View Nodes)
• Includes system verification documents in PDF format
• Compliant with EU GMP Annex 1 and 21 CFR part 11

The enVigil-FMS offers a configurable environmental monitoring software system aimed at Pharmaceutical, Healthcare, Electronic and Satellite production facilities.

enVigil-FMS 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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