1. © 2008, TSI Incorporated TSI FMS 5 Launch Tim Russell August 13th, 2009

2. © 2008, TSI Incorporated Agenda Introduction Overview –What is a monitoring system –Hardware architecture –Software architecture Applications –Regulatory markets FMS 5 Demo –Screenshot demo –Live demo –FMS 5 configuration demo Features and benefits review

3. © 2008, TSI Incorporated FMS software v5 Overview-What is a monitoring system? –Automatically collects data from sensors in the field at user configurable sample intervals –Data collection can span many years –Data is presented as information in the form of reports and trends –Data is processed immediately as an alarm annunciation or a local display –Operators are informed in real-time of an out of specification event

4. © 2008, TSI Incorporated FMS software v5 Overview-What is a monitoring system? –It is not a control system –It is not a building management system –Often called FMS (Facility Monitoring System) IMS (Independent Monitoring System) A validated process monitoring tool DATAKNOWLEDGEINFORMATION

5. © 2008, TSI Incorporated HARDWARE ARCHITECTURE FMS software v5

6. © 2008, TSI Incorporated FMS software v5 Overview- Particle counter hardware field architecture Power over Ethernet (POE)Hub Ethernet Monitoring Computer Sample probe Particle counter Ethernet

7. © 2008, TSI Incorporated FMS software v5 Overview- Environmental hardware field architecture Duct Temp/RH Probe Linear 4-20mA output (i.e. 4mA=0%RH 20mA=100% RH) 4-20mA input to RS485 output module RS485 to Ethernet module RS 485 output Monitoring Computer Ethernet Hub TCP/IP

8. © 2008, TSI Incorporated FMS software v5 An example of a control panel Pressure sensors 4-20mA output 4-20mA input to RS485 output modules RS485 input to Ethernet Output modules Monitoring Computer UPS –Uninterruptable power supply Environmental sensor field wiring in

9. © 2008, TSI Incorporated SOFTWARE ARCHITECTURE FMS software v5

10. © 2008, TSI Incorporated FMS software v5 Sensor Control and data input MYSQL or MSSQL databases supported Relay alarm outputs Email, SMS text outputs Classically all on one computer and are interdependent

11. © 2008, TSI Incorporated FMS software v5 Sensor connections on a separate LAN Distributed design allows for components of the monitoring system to be installed on separate computers Clients do not need to be running for the monitoring system to work

12. © 2008, TSI Incorporated FMS software v5 Automatic hot standby and database mirroring delivers a robust monitoring system Hot automatic standby monitor Monitoring hardware is connected to this separate LAN

13. © 2008, TSI Incorporated APPLICATION and REGULATION FMS software v5

14. © 2008, TSI Incorporated FMS software v5 Applications- –Pharmaceutical Industry EU Grade A, Grade B or FDA ISO 5 (was Fed Std Class 100) –Hospital Pharmacy –Contract manufacturing Particle counting Differential Pressure Temperature/Relative Humidity rooms Fridge temperature Alarm outputs Air velocity FDA cGMP and EUGMP Annex 1 are the regulatory drivers for monitoring systems, where there is aseptic processing of sterile drug products

15. © 2008, TSI Incorporated FMS software v5 Applications- –Tissue banks –Blood Banks –IVF facilities Particle counting Differential Pressure Temperature/relative humidity, rooms and surfaces Cryogenics CO2 and O2 Air velocity Alarm outputs EU Tissue and Cells directive, ISO 9000 and reduced overheads are drivers for monitoring systems

16. © 2008, TSI Incorporated FMS software v5 Applications- –Semi-conductor –Disk Drive –Aerospace Particle counting- smaller particle sizes v pharma Differential Pressure Temperature/Relative Humidity rooms Air velocity Alarm outputs ESD Molecular contamination Improved process control leads to better yields

17. © 2008, TSI Incorporated PHARMA SCREENSHOT DEMO FMS software v5

18. © 2008, TSI Incorporated FMS software v5 Pharma Alarm Groups Sample points Unit Status Sample Point Statistics System Messages Monitoring Node Tab – all available monitoring nodes are shown here Easy to use interface

19. © 2008, TSI Incorporated FMS software v5 Pharma Unique user name and password login 21 CFR part 11 Compliance

20. © 2008, TSI Incorporated Just Groups FMS software v5 Pharma User customized display Screen display shortcut buttons Messages always on

21. © 2008, TSI Incorporated Statistics FMS software v5 Pharma User customized display

22. © 2008, TSI Incorporated Unit Status FMS software v5 Pharma User customized display

23. © 2008, TSI Incorporated Sample points status only FMS software v5 Pharma User customized display

24. © 2008, TSI Incorporated Easy access sample point Inspect wheel FMS software v5 Pharma Fast and easy user access to process critical data

25. © 2008, TSI Incorporated Inspect Window historical and real-time Data list Inspect Window Print options FMS software v5 Pharma Fast and easy user access to process critical data Data Graph Statistics

26. © 2008, TSI Incorporated Inspect Window- Real time graph with limits lines FMS software v5 Pharma Fast and easy user access to process critical data

27. © 2008, TSI Incorporated Inspect Window Inspect Window (Graph) Inspect Window (Statistics) Inspect Window (Alarm Limits) FMS software v5 Pharma Fast and easy user access to process critical data

28. © 2008, TSI Incorporated Graph inspect full screen Real time data update FMS software v5 Pharma Fast and easy user access to process critical data

29. © 2008, TSI Incorporated Alarm Acknowledge is made available on the inspect wheel FMS software v5 Pharma Fast and easy user access to acknowledging alarms

30. © 2008, TSI Incorporated Alarm Acknowledge Reason Alarm Acknowledge username and password required FMS software v5 Pharma Out of specification event tracking via alarm acknowledge

31. © 2008, TSI Incorporated All Alarm Groups listed here Alarm Group Window FMS software v5 Pharma Alarm Groups allow alarms to be mapped to different outputs

32. © 2008, TSI Incorporated Alarm Group Sample Point Inspect FMS software v5 Pharma Fast and easy access for users to process critical data via the Alarm Groups

33. © 2008, TSI Incorporated Map Display Real time sample point data Sample Point Icon FMS software v5 Pharma To help users process critical data can be presented in different ways

34. © 2008, TSI Incorporated Sample Point Inspect FMS software v5 Pharma Fast and easy user access to process critical data is always possible

35. © 2008, TSI Incorporated Map Zoom FMS software v5 Pharma Fast and easy user access to process critical data is always possible

36. © 2008, TSI Incorporated Graph Setup Sample Point Selection Graph shortcut buttons FMS software v5 Pharma User customized graphing for critical process monitoring

37. © 2008, TSI Incorporated Log or linear scaling Multiple or single sample point selection Flyby hints FMS software v5 Pharma User customized graphing for critical process monitoring

38. © 2008, TSI Incorporated Real time graph update FMS software v5 Pharma User customized graphing for critical process monitoring

39. © 2008, TSI Incorporated Multiple Graphs FMS software v5 Pharma User customized graphing for critical process monitoring

40. © 2008, TSI Incorporated Reporting Tabular reports Graphs and plots Statistical summaries Compliance summaries Scheduled reports FMS software v5 Pharma

41. © 2008, TSI Incorporated Reporting shortcut User pre- configured report list Selected report configuration Make new report FMS software v5 Pharma User configurable historical reporting, collected data is turned into information

42. © 2008, TSI Incorporated Report content filter Sample point selection Report name FMS software v5 Pharma User configurable historical reporting, collected data is turned into information

43. © 2008, TSI Incorporated Pre configured report intervals FMS software v5 Pharma User configurable historical reporting, collected data is turned into information

44. © 2008, TSI Incorporated Select sample points to be reported FMS software v5 Pharma User configurable historical reporting, collected data is turned into information

45. © 2008, TSI Incorporated Configurable graph lines FMS software v5 Pharma User configurable historical reporting, collected data is turned into information

46. © 2008, TSI Incorporated User can select which pages are printed Single page compliance summary Reports can be printed or saved FMS software v5 Pharma Reports are generated in PDF format and can be scheduled

47. © 2008, TSI Incorporated System control buttons Sample point recipe configuration tab Monitoring system control shortcut button Real time view of system status FMS software v5 Pharma The system can be easily controlled whilst being able to view the system status

48. © 2008, TSI Incorporated Monitoring system configuration shortcut button Real time view of system status FMS software v5 Pharma The system can be easily configured whilst being able to view the system status

49. © 2008, TSI Incorporated System configuration list- (sample points selected) System sample point list Selected sample point configuration dialog FMS software v5 Pharma The system can be easily configured whilst being able to view the system status

50. © 2008, TSI Incorporated Lockout after failed logins Password duration FMS software v5 Pharma FMS software security features enables compliance to 21 CFR part 11 Windows security is also supported Client locked out after a period of inactivity

51. © 2008, TSI Incorporated STANDARD SCREESHOT DEMO FMS software v5

52. © 2008, TSI Incorporated Open a new window shortcut button System login Open a saved screen display configuration Initial blank screen FMS software v5 Standard Standard mode allows total user control over displayed data on their monitoring system

53. © 2008, TSI Incorporated Open a new status window Monitoring system or node is selected here FMS software v5 Standard Standard mode allows the user to display data only of interest to themselves, even across multiple monitoring systems

54. © 2008, TSI Incorporated A new status window A status window displayed as a list FMS software v5 Standard Standard mode allows the user to display data only of interest to themselves, even across multiple monitoring systems

55. © 2008, TSI Incorporated Graph configuration FMS software v5 Standard

56. © 2008, TSI Incorporated Graph statistics FMS software v5 Standard Advanced Graphing Graph dual axis

57. © 2008, TSI Incorporated FMS software v5 Standard The customized view can be saved by the user and recalled later

58. © 2008, TSI Incorporated FMS software v5 Standard The user customized view can be saved and recalled later Real Time Map Display Real Time Sample Point Status Report Configuration Real Time Graph Display

59. © 2008, TSI Incorporated FMS software v5 Standard Security- User groups allow customization of user specific privileges User Groups

60. © 2008, TSI Incorporated FMS software v5 LIVE DEMO

61. © 2008, TSI Incorporated Meets FDA cGMP and EUGMP Annex 1 guidelines Enables compliance to FDA 21 CFR Part 11 Password protected with password aging Audit trails Log changes or revisions of configuration User acknowledgment for system alarms Customized security user groups Fully validated turnkey solution Full GAMP © 5 software development lifecycle documentation FMS software v5 Features Life-sciences

62. © 2008, TSI Incorporated Robust, distributed design supports Automatic hot standby monitoring system (buddy) Built-in redundancy with database mirroring Multiple clients Easy-to-use user interface Large install base Displays graphs, charts, sample point status Displays statistics (SPC) and graphs FMS software v5 Features General

63. © 2008, TSI Incorporated Displays cleanroom compliance reports All Reports can be real-time or scheduled for convenience Reports can be printed as required Exports reports to CSV Prints and generates reports in PDF formats Compatible with Microsoft SQL, MySQL databases FMS software v5 Features General

64. © 2008, TSI Incorporated Alarm light towers and audible alarms Email messages SMS messages Phone notification FMS software v5 Features General

65. © 2008, TSI Incorporated FMS software v5 Features Power-over-Ethernet (PoE) MODBUS RTU and ASCII 4-20mA Inputs Voltage Inputs Digital Inputs Digital and Analog Outputs Multiple interfaces

66. © 2008, TSI Incorporated Easy-to-use Intuitive user interface means immediate visibility of real-time data, one or two click access to historical data and report generation, leads to reduced operator training overheads, immediate response to out of specification events and improved process control. FMS software v5 Benefits

67. © 2008, TSI Incorporated Robust and Reliable Built in system redundancy with real-time database mirroring, automatic hot standby (buddy) monitoring systems means no manual intervention is required if your monitoring computer should fail. The result is no system down time, no lost data and best of all, peace of mind. FMS software v5 Benefits

68. © 2008, TSI Incorporated Enables 21 CFR part 11 Compliance Full audit trailing, password ageing and lockout after failed logins, means secure, tamper proof data archiving and reporting. System security is configurable, user groups allow users and managers appropriate levels of system access. FMS software v5 Benefits

69. © 2008, TSI Incorporated Alarm generation Multiple outputs; beacons, sounders, SMS text, email and auto-dialers are supported, operators and managers are immediately informed of an out of specification event, leading to improved root cause investigations, improved process understanding and improved product quality.. FMS software v5 Benefits

70. © 2008, TSI Incorporated In house software development team TSI provides compliant and relevant environmental monitoring systems to all supported markets sectors, all software development activities are tightly controlled and follow the ISPE GAMP ® software lifecycle model. FMS software v5 Benefits

71. © 2008, TSI Incorporated Finally…. How to order FMS software Issued next week –TSI Price catalogs –TAP addenda contain applicable discount levels Software protection –Hardware Security key –Software License key

72. © 2008, TSI Incorporated Finally…. Useful links –FDA cGMP www.fda.gov/downloads/drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070342.pdf –EUGMP Annex 1 http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-4/2008_11_25_gmp-an1.pdf –ISPE GAMP 5 http://www.ispe.org/cs/gamp_publications_section/gamp_publications_overview

73. © 2008, TSI Incorporated Thank You