Lighthouse Worldwide Solutions

Sept. 21, 2006
Facility Monitoring Software Facilitates 21 CFR Part 11 Compliance

Lighthouse Worldwide Solutions (San Jose, Calif.), a leader in contamination monitoring solutions, has joined with Facility Monitoring Systems (Malvern, U.K.) to announce the expansion of their global business partnership and the distribution of FMS3 advanced monitoring software for the pharmaceutical and biomedical markets.

The partnership between Lighthouse Worldwide Solutions and Facility Monitoring Systems has many benefits for both companies and their pharmaceutical and biomedical customers. It will provide leading edge instrumentation, validation support, 24-hour worldwide service, software technology and also the very best in technical solutions through applications technology.

Lighthouse Worldwide Solutions has offices throughout the Far East and extensive agent/distributor partnerships, that provide a unique business platform to sell and support contamination and monitoring solutions worldwide.

Contact information for Facility Monitoring Systems Ltd.:

Unit 5, Beauchamp Business Centre
Sparrowhawk Close
WR14 1GL
United Kingdom

Telephone: +44 (0)8702 410 862
Fax: +44 (0)1684 576934
E-mail: [email protected]

Facility Monitoring Systems has created FMS3 following GAMP guidelines, advanced reliable and user-friendly monitoring software for the pharmaceutical and biomedical industries. This product facilitates 21 CFR Part 11 compliance and provides complete and secure monitoring of all environmental parameters such as particle counts, temperature, pressure and relative humidity.

FMS3 software also boasts a world’s first in being supplied not only in CD format for client and server applications but also pre-installed on a mini PC such as World’s Smallest PC. Supplying pre-configured software on a small PC resolves many of the security issues implicit in 21 CFR Part 11 simplifying technical support. FMS3 uniquely offers “Buddy” hot standby monitoring system functionality, in the event the main monitoring computer is shut down or fails, the monitoring of critical processes continues uninterrupted.

FMS3 System Specifications follow:


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


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


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


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.


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


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


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


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


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

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