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Configure alarm conditions, notifications, and audit trail for compliance. Learn to create alarm groups, define triggers, and set up logging for FDA 21 CFR Part 11 compliance.

What You'll Learn

Alarms & Audit-Trail (Tutorial) teaches you to:

  • Create alarm groups and items
  • Configure alarm conditions
  • Set up notifications
  • Enable audit trail for FDA 21 CFR Part 11 compliance

Prerequisites:

In this page:

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Alarms → Tutorial | Concept | How-to Guide | FDA 21 CRF 11 | Reference

configured in UNSUnderstanding of alarm priorities



Step 1:

Create

Configure Alarm Groups

  1. Navigate to Alarms → Groups
  2. Add Verify pre-defined groups exist:


Group

Critical Alarms:

  • Name: Critical
  • Priority: 1
  • Acknowledgment: Required
  • Sound: Critical.wav
  • Color: Red

Warnings:

  • Name: Warnings
  • Priority: 3
  • Acknowledgment: Optional
  • Color: Yellow
AckRequiredLogEventsPriority
CriticalTrueTrueHigh
WarningFalseTrueMedium
AuditTrailFalseTrueHidden


Modify Critical group:

    • Open the ComboBox Sound field
    • Select Exclamation
    • Press Enter

Step 2: Create

Step 2: Define

Alarm Items

  1. Go to Alarms → Items
  2. Create Add high temperature alarm:

High Temperature:

  • Name: Tank1_HighTemp
  • Group: Critical
  • Tag: Tank1_Temperature
  • Condition: Greater than
  • Limit: 85
  • Message: "Tank 1 temperature exceeds limit"
  • Deadband: 2

Low Level:

  • Name: Tank1_LowLevel
  • Group: Warnings
  • Tag: Tank1_Level
  • Condition: Less than
  • Limit: 10
  • Message: "Tank 1 level low"

Step 3: Configure Deviation Alarms

For rate-of-change monitoring:

  • Name: Pressure_Deviation
  • Type: Deviation
  • Tag: Line_Pressure
  • Setpoint Tag: Pressure_Setpoint
  • Deviation: ±10
  • Time: 60 seconds

Step 4: Set Up Email Notifications

  1. Navigate to Alarms → Groups
  2. Select group → Email settings:
PropertyValue
TagNameTag.TankFarm/Tank1/Temp
ConditionHiHi
Limit85
GroupCritical
MessageTank 1 Critical Temperature: {Tag.TankFarm/Tank1/Temp}°C
Priority100
  1. Add low level alarm:
PropertyValue
TagNameTag.ankFarm/Tank1/Level
ConditionLo
Limit20
GroupWarning
MessageTank 1 Low Level Warning
Priority50

Step 3: Configure Alarm Areas

  1. Navigate to Alarms → Areas
  2. Create hierarchy:
  • Plant
    • Production
      • Tank1
      • Tank2
    • Utilities
  1. Assign alarms to areas:
    • Return to Alarms → Items
    • Set Area = Plant.Production.Tank1 for both alarms

Step 4: Enable

Step 5: Configure

Audit Trail

  1. Go to Alarms → Global Settings
  2. In Audit Trail section:
    • Check Enable
    logging
    • Audit Trail
    • Enable options:
        Login/Logout: Yes
        • User Logon/Logoff
        • Tag Changes
        : Yes
      • Alarm Acknowledgments: Yes
      • Configuration Changes: Yes
    • Set storage:
      • Database: SQL Server
      • Table: AuditTrail
      • Retention: 365 days

Step 6: Create Alarm Areas

For plant organization:

  1. Alarms → Areas
  2. Create hierarchy:
Plant/
  ??? Production/
  ?   ??? Line1/
  ?   ??? Line2/
  ??? Utilities/
      ??? Boilers/
      ??? Compressors/
  1. Assign alarms to areas

Step 7: Test Alarms

  1. Start Runtime
  2. Open Alarms → Online
  3. Force tag values to trigger alarms
  4. Verify:
    • Alarm appears in list
    • Color coding correct
    • Sound plays
    • Email sent

Step 8: Alarm Summary Display

Create operator display:

  1. Displays → New
  2. Add AlarmViewer control
  3. Configure:
    • Show: Active alarms
    • Columns: Time, Area, Message, Value
    • Filter: By area or priority
    • Allow: Acknowledge, silence

FDA 21 CFR Part 11 Setup

For compliance:

  • Electronic signatures on acknowledgments
  • Audit trail cannot be disabled
  • User authentication required
  • Time synchronization enabled
  • Data integrity checksums

Best Practices

  • Use consistent naming conventions
  • Set appropriate priorities (1-5)
  • Include clear messages
  • Test all alarm conditions
  • Document alarm philosophy
  • Regular alarm rationalization

Next Steps

  • [Historian] - Store alarm history
  • [Reports Module] - Alarm reports
  • [Security Module] - User permissions
        • Operator Actions
        • Custom Messages
    1. Configure database retention:
      • Life Time: 2555 days (7 years for FDA compliance)

    Step 5: Create Alarm Display

    1. Navigate to Displays → New
    2. Name: AlarmMonitor
    3. Add AlarmViewer control from toolbox
    4. Configure properties:
      • List: OnlineAlarms
      • ShowAcknowledged: False
      • Columns: Time, TagName, Message, Value, Group
    5. Add AlarmArea control for navigation
    6. Save display

    Step 6: Test Alarms

    1. Start Runtime (Runtime → Startup)
    2. Open Runtime → Online Alarms
    3. Simulate alarm conditions:

    csharp

    // In Script Task or Watch Window
    @Tag.Tank1_Temp = 90;  // Triggers high temp
    @Tag.Tank1_Level = 15; // Triggers low level
    1. Verify in AlarmViewer:
      • Critical alarm shows red
      • Warning shows yellow
      • Sound plays for Critical
      • Acknowledge required for Critical
    2. Test acknowledgment:
      • Right-click Critical alarm
      • Select Acknowledge
      • Verify state change

    Step 7: Verify Audit Trail

    1. Change AlarmViewer List to AuditTrail
    2. Verify logged events:
      • User login
      • Alarm triggers
      • Acknowledgments
      • Tag changes
    3. Add custom message via script:

    csharp

    @Alarm.GlobalSettings.AuditTrail.AddCustomMessage(
        "Tutorial test completed by " + @Client.UserName
    );

    Next Steps

    • [Configure Email Notifications] - Set up SMTP
    • [Create Alarm Reports] - Historical analysis
    • [FDA Compliance Setup] - Full 21 CFR Part 11

    Step-by-step guide to configure alarm groups, conditions, notifications, and audit trail for operational monitoring and FDA compliance.


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