Life Science FMS 5.0 PN5001263 A4...
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Facility Monitoring Systems CONTAMINATION CONTROL The Leading Facility Monitoring Software FMS 5.0 TRUST. SCIENCE. INNOVATION.
Transcript of Life Science FMS 5.0 PN5001263 A4...
Fac i l i t y Mon i to r ing Sys tems
C O N T A M I N A T I O N C O N T R O L
The Leading Facility Monitoring Software FMS 5.0
TRUST. SCIENCE. INNOVATION.
FMS 5.0, the LeadingFacility Monitoring SoftwareTSI FMS system is an advanced, reliable, and user-friendly monitoringsoftware suite that features a truly open architecture, supportingmultiple instrument inputs from any manufacturer. Typicalinputs include:� Airborne particle counters� Temperature and humidity sensors� Differential pressure gauges� Liquid particle counters� ESD� Airborne molecular contamination and more
Features and Benefits� Open architecture� Meets all regulatory guidelines for GMP pharmaceutical production� Fully GAMP® compliant� Enables 21 CFR Part 11 compliance� Built-in system redundancy� Unique Buddy automatic hot standby option� Back up via mirror database � Intuitive operation� Multi-level maps� Notifications via email, SMS and telephone� Display and auto reporting� User defined reporting� Easy data export� Group, acknowledgement, and auto alarms� SPC control charts
Regulatory ComplianceFMS 5.0 is compliant environmental monitoring system software forthe Pharmaceutical, Medical Device and Life Science industries. Allsoftware development activities at TSI follow the ISPE GAMP® lifecyclemodel. FMS 5.0 is assigned current GAMP® as a configurablesoftware. It is specifically intended for use where compliance to EUGMP Annex 1 and the aseptic processing FDA cGMP is required.
FMS 5.0 enables compliance to the FDA 21 CFR Part 11 ruling. Fullaudit trail, password aging and lockout after failed logins, ensuressecure, tamper proof data archiving and reporting. System security iseasily configurable. User groups allow users and managersappropriate levels of system access.
ValidationFull project based validation lifecycle documentation based on the latestISPE GAMP® guidelines is available and tailored to meet yourrequirements.
� User Requirement Specification (URS)� Functional Specification (FS)� Configuration Statement (CS)� Factory Acceptance Test (FAT)� Installation Qualification (IQ)� Operational Qualification (OQ)
Ensure Regulatory
21 CFR Part 11: Unique user name and password
Compliance with FMS 5.0
Ease of UseAn intuitive, userconfigurable interfacemeans immediatevisibility of real-timedata. Single mouse clickaccess to historical dataand report generationleads to reducedoperator training,immediate data accessand improved process control.
Graphing & ReportingFMS comes with its ownreport generation tool.This allows users to createcustomized reports tomeet your needs. Wheremore advanced reportingis required, third partytools can be easilydeployed to use with FMS5.0 databases. Allcollected data can be turned into useful process information viapowerful FMS 5.0 reporting and graphing tools. Critical reports can begenerated each day, and auto reports can be created based onrecorded events.
MappingMulti-level maps displaythe last recorded valuefor each instrument andshow real-time icons inRed for Alarm, Yellow forWarning, Green for Okand Blue for instrumentfailure. Simply click onthe intrument icon forinstant, detailed information.
CommunicationFMS 5.0 supportsmultiple system outputslike beacons, sounders,SMS text, email, auto-dialers and reporting aresupported. Operatorsand managers areimmediately informed ofan event. Thisinformation aids in rootcause investigations, process validation and improved product quality.
Need a Buddy?FMS offers a unique Buddy (Automatic HotStandby) system option for built-in systemredundancy. This completely integrated back-upsystem resides on an alternate computer. Ifanything happens to the primary FMS 5.0system, the Buddy automatically takes over,continuing to collect secure data. No manualintervention is required in the event of acomputer failure, meaning no system downtime, no lost validated data, and peace of mind.
TSI Incorporated - 500 Cardigan Road, Shoreview, MN 55126-3996 USA
USA Tel: +1 800 874 2811 E-mail: [email protected] Website: www.tsi.comUK Tel: +44 149 4 459200 E-mail: [email protected] Website: www.tsiinc.co.ukFrance Tel: +33 491 11 87 64 E-mail: [email protected] Website: www.tsiinc.frGermany Tel: +49 241 523030 E-mail: [email protected] Website: www.tsiinc.deIndia Tel: +91 80 41132470 E-mail: [email protected] Tel: +86 10 8260 1595 E-mail: [email protected] Tel: +65 6595 6377 E-mail: [email protected]
Contact your local TSI Distributor or visit our website www.tsi.com for more detailed specifications.P/N 5001221 Rev A Copyright © 2010 by TSI Incorporated Printed in U.S.A.
TSI Incorporated serves a global market by investigating, identifying and solving measurement problems. As an industry leader in the design and production of precisioninstruments, TSI partners with research institutions and customers around the world to set the standard for measurements relating to aerosol science, air flow, health andsafety, indoor air quality, fluid dynamics and biohazard detection. With headquarters based in the U.S. and field offices throughout Europe and Asia, TSI has established aworldwide presence in the markets we serve. Every day, our dedicated employees turn research into reality.
Facility Monitoring System Overview:
Temp/RH
CO2
DifferentialPressure
AeroTrak RemoteParticle Counters
AeroTrak Portable Particle Counters
Buddy PC
View ClientView Client
Email Alertsand SMS (text) Alerts
I/O Panel
POE Hub
AlarmBeacon
MirrorDatabase
Main FMS monitor Main Database
Airflow
Dedicated or Corporate LAN
