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Introduction to the

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Overview

The Security

Module:
  • Manage user access, roles, and permissions. 
  • Control who can access, view, and modify solution components. 
  • Control who can manage runtime user interactions with displays and actions

    module manages user authentication, authorization, and access control for both engineering and runtime environments, ensuring compliance with FDA 21 CFR Part 11 and other regulatory requirements.

    On this Page:

    Table of Contents
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    Key Concepts

    and Terms

    • *Users
    Anyone
    • *: Individuals accessing the solution
    , either
    • in Designer (engineering
    (Designer Tool
    • ) or
    in
    • runtime
    mode
    • (
    Displays
    • displays)
    .

    Permissions

    Permissions are set levels of access for each user that determine what they can or cannot do within the solution.

    Policies

    Policies manage requirements on User Identification and Session Control.

    RuntimeUsers

    These users are created and retrieved from an external encrypted SQL database or other identification servers.

    Features Highlights

    The Security Module in FactoryStudio provides a range of features to ensure comprehensive security for your projects. Key features include:

    • *Permissions*: Access levels determining what users can view, modify, or execute
    • *Policies*: Requirements for user identification, passwords, and session control
    • *RuntimeUsers*: Dynamic users managed in external databases or authentication servers
    • *Permission Groups*: Collections of users sharing common permission sets

    What It Does

    • Manages user authentication and authorization
    • Controls access to engineering and runtime components
    • Enforces password policies and session management
    • Integrates with Active Directory and LDAP
    • Maintains audit trails for compliance
    • Supports electronic signatures
    • Enables dynamic runtime user creation

    Configuration Workflow

    Security Module Configuration Workflow

    Step

    Action

    Description

    Define Groups

    Create user groups

    Set permission levels for each group

    Create Users

    Add user accounts

    Assign users to groups and set individual permissions

    Configure Policies

    Set security rules

    Define password requirements and session controls

    Setup External Auth

    Configure AD/LDAP

    Connect to enterprise authentication systems

    Define RuntimeUsers

    Configure database

    Setup encrypted SQL storage for dynamic users



    Runtime Behavior

    Authentication

    Users authenticate through local credentials, Active Directory, LDAP, or external databases. Session policies control timeout, concurrent logins, and automatic logoff.

    Authorization

    Permissions are evaluated at multiple levels:

    • Global solution access
    • Module-specific operations
    • Display and object visibility
    • Runtime actions and commands

    Audit Trail

    All security events are logged including logins, permission changes, and critical operations for compliance tracking.


    Features Highlights

    • *Group-Based Permissions* - Define access levels by user groups
    • *Active Directory/LDAP Integration* - Enterprise authentication support
    • *Runtime User Management* - Create/modify users without project changes
    • *FDA 21 CFR Part 11 Compliance* - Electronic signatures and audit trails
    • *NERC-CIP Support* - Critical infrastructure protection features
    • *Multi-Level Security* - Global, module, display, and object-level permissions
    • *Session Management* - Timeout, concurrent login, and auto-logoff policies
    • *Encrypted Storage* - Secure credential storage in SQL databases
    • *E-Signatures* - Electronic signature requirements for critical operations
    • *.NET Security Framework* - Built on managed code security guidelines
    • *Third-Party Integration* - Connect to external authentication systems
    • User Management: Easily create and manage user profiles with customizable access levels to project components.
    • Group-based Permissions: Define the access level for each user group within the project.
    • Session Policies: Manage user identification and session control requirements.
    • Runtime Users: Dynamically add and remove users without needing to modify the project.
    • Integration with Active Directory and LDAP: Seamlessly streamline user management across your organization.

    Security

    FDA 21 CFR Part 11 and NERC 

    Our software platform offers various security and compliance features to assist organizations in meeting the requirements of FDA 21 CFR Part 11. It's important to recognize that compliance is a continuous process. Therefore, organizations should consistently monitor and update their systems and policies to ensure alignment with the standards set by the FDA.

    Built-in .NET Security 

    Our platform’s development relies on .NET and utilizes managed code, adhering to security guidelines. Development with .NET managed code must comply with .NET rules. Specific guidelines are tailored for different modules. For instance, Alarms adhere to FDA guidelines, while Electrical device communications adhere to IEC61850 standards, among others. Below, we'll outline the main FS-Security topics along with some basic information about each.

    Group and User Permissions 

    Using our platform, you have total flexibility to define privileges based on groups or individual users. Permissions can be set globally or linked to specific displays, objects, or input actions.

    Runtime Users 

    Easily create users on the fly and store their credentials in SQL databases. You can also retrieve users from Active Directory or third-party systems for integrated security and unified login.

    User Policies

    We offer a complete set of user management features, including identification policies, session duration control, automated logoff, e-signatures, audit trails, and more.

    Redundancy

    Hot-standby Fault-tolerant Servers 

    Our platform provides reliable and easily configurable redundancy for seamless failover. It automatically initializes and synchronizes the primary and secondary servers. Additionally, setting up redundant physical networks and PLC nodes for device communication channels is straightforward.

    Database Redundancy

    You can assign the Alarm and Historian database to a third-party external cluster, or they can be automatically replicated when running on the platform’s servers.

    Project Configuration Synchronization

    The engineering tools offer features that simplify configuration and updates in redundant scenarios.

    Hot-swapping

    Redundant or stand-alone servers enable seamless switching of project versions, ensuring uninterrupted service for connected clients while maintaining the real-time database loaded.

    Redundancy at the Core Level 

    All modules, including Real-Time tags, Devices, Alarms, Historian, Scripts, and Clients, were built from the ground up to meet redundancy and hot-swapping requirements.

    Redundancy can be set individually for each Execution Profile (Development, Testing and Production)