Alarms & Audit-Trail tutorial teaches how to 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.

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What You'll Learn

  • Create alarm groups and items
  • Configure alarm conditions
  • Set up notifications
  • Enable audit trail

Prerequisites

  • Tags configured in UNS
  • Understanding of alarm priorities

Step 1: Create Alarm Groups

  1. Navigate to Alarms → Groups
  2. Add groups:

Critical Alarms:

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

Warnings:

  • Name: Warnings
  • Priority: 3
  • Acknowledgment: Optional
  • Color: Yellow

Step 2: Define Alarm Items

  1. Go to Alarms → Items
  2. Create 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:

Step 5: Configure Audit Trail

  1. Go to Alarms → Audit Trail
  2. Enable logging:
    • Login/Logout: Yes
    • Tag Changes: Yes
    • Alarm Acknowledgments: Yes
    • Configuration Changes: Yes
  3. 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