FDA 21 CFR Part 11 requirements

Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

Listed below are described some security-related features available in the product:

• Access Control: Security technique that regulates who or what can view or use resources in a computing environment.
• Password Encryption: System administrator does not possess access to the user. They are encrypted before being stored.
• Maximum and Minimum Age for Password: A feature that imposes a minimum password age before allowing it to change and a maximum age before expiring.
• Required Password changing: Forces the user to alter his password after the first login has been made.
• User Name and Password Minimum Length: Defines username and the password's minimum length.
• Block on Invalid Login Attempt: Blocks User if maximum number of invalid login attempts have been made.
• Store Password History: A range of the last 0-5 passwords can be stored to make sure the user does not repeat an already used one.
• Auto Log Off: User is logged off the system for inactivity or expiration date.
• Audit Trail Data: Security-relevant chronological record or set of records that provide documentary evidence of the sequence of activities that have affected at any time a specific operation.

Project Configuration

Audit Trail

Audit trails should be generated independently of the operator and include the local date and time of the actions that alter the record. They cannot overwrite the old data, and they must be stored as long as the record itself is stored.

To use the Audit Trail function, you must enable it. Go to Edit → Alarms → Groups, and click the Settings button.

A popup display will open with many checkboxes. Besides the Enable option, you can choose which actions will be stored in the Audit Trail database. The options are as follows:

• User Logon/Logoff: Stores informational data on user login/logout.
• Open/Close Displays: Stores informational data when displays are open or closed.
• Remote Connections: Stores information on remote client connections (Smart/Rich Clients).
• Custom Messages: Stores added custom messages.
• Tag Changes: Stores informational data of every tag change.
• Datasets (Insert/Updates or All Commands): Stores information on datasets.
• Operator Actions: Stores information on operator actions.
• Save Reports: Stores information when the save command is executed.
• System Warnings: Stores information related to the system.

For every project update indicated above, crucial information is stored alongside the event info in the Alarm Historian database columns:

• UserName: Indicates the user that was logged in at the time an event happened.
• ActiveTime Ticks: Date and time in which the event happened. It is worth mentioning that, despite this data being stored as Ticks in the database, the product is smart enough to automatically convert it to DateTime when it shows on a Display.
• Message: Detailed information on the event. It changes according to the event.
• Condition: Indicate which Audit Trail selection field the event came from.

Exporting Reports

To comply with the regulation, the software must be able to export digital and physical copies of Reports.

To create or edit a report:

• Go to Edit → Reports → Reports
• Select a report name or select the insert row (first row)
• Enter or select information, as needed

• Name: Enter a name for the report. The system will let you know if the name is not valid.
• Padding: Use padding when replacing a tag name with its value (the field starts with enough space for the same number of characters as the tag name):
  • Compact — Removes any extra characters and displays only the tag.
  • PadRight — Adds an extra space for each character to the right of the tag.
  • PadLeft — Adds an extra space for each character to the left of the tag.
• SaveFormat: Selects the report format: XPS, HTML, Unicode, ASCII, PDF.
• SaveFileName: Enter a string with {ObjectProperties}. Use the full path.
• SaveTrigger: Enter an object property as the trigger.
• Append: Enter the file that appends the report.
• Size: The size of the report.
• EditSecurity: Check which user groups can edit the report.
• Header: Choose another report as the Header.
• Footer: Choose another report as the Footer.
• Legacy: Read-only. Shows if the report is a legacy.
• Description: Enter a description of the report.

It is possible to add several runtime objects to a Report. Some examples are:

• Tag values and properties.
• Client and Server property information.
• Symbols (TrendCharts are added as a symbol).
• Tables and DataGrids can be dynamically colored and translated according to the project’s localization setting.

The Report is saved using one of the following methods:

@Report.<ReportName>.Save
// Property used to trigger the save report action

@Report.<ReportName>.SaveCommand(int Orientation)
// Orientation = 0 or blank -- Portrait Mode
// Orientation = 1 -- Landscape Mode
// saves the selected report into the path indicated by the SaveFileName property

Security User Permissions

On Security → Permissions, it is possible to allow/disallow a user to edit different project tabs in the Engineering Environment. The available options are shown in the image below.

It is also possible to allow/disallow a user to perform different actions during Runtime.

To apply a created permission to a user, go to Security → Users (Permissions Columns), and select the desired option.

Security User Policies

On Security → Policies, there are three main configuration columns that can be important for CFR 11 compliance.

• Identification: Contains several password configuration options, detailed below:
  • Allow Password Change: Indicates if a user, other than an administrator, can change its own password.
  • Password Min Length: Minimum character length for password (0 means no restrictions).
  • Block On Invalid Attempts: Maximum number of login attempts before blocking user (0 means no restrictions).
  • Allow Share User: Indicates if user can be shared between stations.
  • UserName Min Length: Minimum character length for username (0 means no restrictions).
  • Password History: Remember last passwords (Range: 0-5).
  • Min Password Age: Minimum password age in hours (0 means no restrictions).
  • Max Password Age: Maximum password age in hours (0 means no restrictions).
  • Block Aging: Maximum blocking age in hours (0 means no restrictions).

• ESign: When enabled, a password will be requested for Action Dynamics with eSign. The password remains valid for a specified timeout time (in minutes).

• Session: User can be logged off according to a determined Inactivity Time (in minutes) and/or after a maximum session duration (in hours).

To apply a created session configuration to a User, go to Security → Users (Policies Columns), and select the desired option.

FDA Compliance Table

This table can be used as check list and auxiliary tool on the certification process.

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