FMS3 SYSTEM FOR PHARMACEUCTICALS
21 CFR Part 11 compliant
Developed under GAMP guidelines
Unique “Buddy” hot standby monitoring system
Operates under 32 Bit Windows™ NT, 2000, XP
Non-viable particle counts
Temperature and relative humidity
Room-to-room pressure differential
Alarms to operators and other systems
Manual data entry

SECURE DATABASE
SQL database formats supported
Only main program has access to database
Mirror or duplicate databases supported
Networked back up supported
Simplifies validation by supporting multiple clients
Single database for ease-of-operation

USER ACCESS CONTROLS
Multi-level permissions
Unique user ID using passwords
Auto log out for user inactivity
Administrator can disable user access

HISTORICAL REPORTS
Historical reports can be defined by:
• Start date and time
• End date and time
• Specific measurement points
Alarm limit lines can be printed on graphs
Can display to screen or print
Readily re-creatable (supporting 21 CFR Part 11)
Can be sent to an email address automatically
Can be created as a pdf document.

AUDIT TRAILS
Provide activity record per 21 CFR Part 11
System can be set to require password for:
• Making system changes
• Acknowledging alarms
Audit trail log can be printed
Can print alarm, event, or activities logs

FACILITY MAPS
Each client can have a unique map or maps
Map points can be triggered to provide current data

BATCH REPORTS
Batch history reports can be defined by
• Start date and time
• Stop date and time
• Specific batch events
• User entered batch name

ALARMS
Four levels of alarm include:
“Low/Low”, “Low”, “High”, and “High/High”
Alarm groups can be used to trigger events
And enunciate alarms/ alarm beacons
Supports SMS text messaging

HARDWARE SUPPORTED
Room-to-room pressure differential
Temperature and humidity
Air Velocity
PLC inputs and outputs
(Modbus TCP, OPC client/server)
Liquid parameters
(Liquid particle counts, TOC ph, and more)
Airborne particle counters
Individual counters (auto data retrieval)
Manifold/Scanner multi-port system