FACTORY ACCEPTANCE TESTING DOCUMENTATION

PARTICULATE MONITORING SYSTEM XXXXXXXXXXXXXX

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Issue: Version 1.0 Date: Reference: FAT

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Table Of Contents
Item
1 Revision History 2 Introduction 3 Hardware Configuration Tests 3.1 3.2 3.3 3.4 3.5 3.6 Inspection - Cabinet Build Quality Inspection - External Layout Inspection - Internal Layout Earth Bonding Signal / Screen Earth Bar Power Supplies 3.6.1 3.6.2 3.6.3 4.1 4.2 4.3 4.4 4.5 AC Power Supply 24 Volt DC Power Supply Redundant Power Supply

Description

Page
4 4 5 5 6 7 9 10 11 11 12 14 15 15 17 19 22 23 23 23 24 24 24 25 25 26 27 27 27 27 28 28 29 29 30 31 31 31 31 31 31 32 32

4 Input / Output Tests Cabinet Inputs (0mA & 4.00mA) Cabinet Inputs (12.00mA & 20.0mA) Accurate Records Cabinet Outputs (Beacons) Power Supply Failure Notification 4.5.1 4.5.2 4.6 4.6.1 4.6.2 4.6.3 4.6.4 5.1 Redundant Power Supplies Cabinet Power Cabinet Network Communications Control Node Network Communications Reporting Node Network Communications View Node Network Communications

Network Communications

5 Software Configuration Tests Security Functions 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6 5.1.7 5.1.8 5.1.9 5.1.10 5.1.11 5.1.12 5.1.13 5.1.14 5.1.15 5.1.16 OS Log-on (Server) OS Log-on (Control Node) OS Log-on (Reporting Node) OS Log on (View Node) InTouch Log-on Auto Log-off Timeout InTouch Log-on User Levels Change Password Password Length Change Initial Password Assignment Auto Rejection After N Consecutive Password Failures Password Ageing Date & Time Synchronisation to Server Windows OS Vulnerability Audit Log Version Control

Item
5.2 5.2.1

Description
Navigation, Operation and Functions - Logged On Control Screen - Logged On 5.2.1.1 Suite Overview Screen 5.2.1.1.1 5.2.1.1.2 5.2.1.1.3 5.2.1.1.4 5.2.1.1.5 5.2.1.1.6 5.2.1.1.7 5.2.1.1.8 5.2.1.1.9 5.2.1.1.10 5.2.1.1.11 5.2.1.1.12 5.2.1.1.13 5.2.1.1.14 5.2.1.1.15 5.2.1.1.16 5.2.1.1.17 5.2.1.2 5.2.1.3 5.2.1.4 5.2.1.5 LYO Zoom Screen Aseptic Vial Processing Zoom Screen Clean Prep and Aseptic Staging Zoom Screen Formulation & Buffer Prep Zoom Screen Real Time LYO Screen Real Time Aseptic Staging & LYO Aisle Screen Real Time Filling Line & Buffer Table Screen Real Time Sterilisation Tunnel & Discharge Screen Real Time Clean Prep Screen Real Time Formulation & Buffer Prep Screen Alarm Viewer Screen Historical Trend LYO Screen Historical Trend Aseptic Staging & LYO Aisle Screen Historical Trend Filling Line & Buffer Table Screen Historical Trend Sterilisation Tunnel & Discharge Screen Historical Trend Clean Prep Screen Historical Trend Formulation & Buffer Prep Screen

Page
33 33 36 40 43 46 48 51 53 55 57 59 61 63 68 78 88 98 108 118 128 129 130 133 150 150 152 171 172 173 178 179 180 182 182 183

System Diagnostic Display Screen Windows Controls Screen Alarm Point Control Screen System Status & Information Panel

5.3 5.4 5.5 5.6 5.7 5.8 5.9

Navigation, Operation and Functions (Not Logged On) 5.3.1 Control Screen (Not Logged On) Particle Count Alarms, Displays and Alarm Outputs Temperature Controlled Counter (Temp Sensor) Alarm Exception Report Data Storage Backup Software Licences

6 Tests Report 7 Test Equipment List 8 Signatures Record APPENDIX Copies of Calibration Certificates for Test Instruments