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FDA 21 CRF 11 | Reference

Step 1:

Configure Alarm Groups

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

Critical Alarms:

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

Warnings:

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

Modify Critical group:

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

Step 2: Create

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:
   • SMTP Server: mail.company.com
   • Port: 587
   • From: scada@company.com
   • To: operators@company.com
   • Subject: "Critical Alarm: {AlarmName}"

1. Add low level alarm:

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

Audit Trail

1. Go to Alarms → Global Settings
2. In Audit Trail section:
   • Check Enable Audit Trail
   • Enable
   logging
   • 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

1. • • Operator Actions
     • Custom Messages
2. 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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