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

  • 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