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.
On this Page
(Concept) 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.
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Key Concepts
and Terms- *Users
- *: Individuals accessing the solution
- in Designer (engineering
- ) or
- runtime
- (
- 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:
- 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)- *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
What's Next
- [Security Module (How-to Guide)] - Step-by-step configuration
- [FDA 21 CFR Part 11 Compliance] - Regulatory setup
- [Security Module (Reference)] - Detailed properties
In this section...
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