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Introduction

FrameworX was designed to enable applications on mission Our platform caters to mission-critical systems , in various segments, including Energy, with NERC requirementsin sectors like Energy, Oil & Gas, and Pharma with FDA requirements, and various other segments. Independently of regulations requirements, all applications, small to large, HMI to IoT, benefits from the stable, reliable infra-structure and strong security protections inherent. to the platform. This section will address some of those . Whether meeting NERC or FDA standards, it provides a stable, secure infrastructure from HMI to IoT. This section delves into key features.

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Security Highlights

Security and Reliability

We prioritize stability and security throughout our platform's design, from technology selection to module architecture.

Easy Configuration and Maintenance

Our platform offers secure, straightforward configuration and maintenance for various scenarios, ensuring scalability and consistency.

Operational Stability

Operational stability is guaranteed with our platform's 100% managed code implementation, featuring robust exception handling and seamless failure recovery.

Redundancy and Availability

For high availability, our platform offers redundancy with a proven hot-standby system for real-time databases, alarms, and historians, catering to diverse network setups.

FDA 21 CFR Part 11 and NERC

The software platform has a range of security and compliance features that can be used to help organizations meet the requirements of FDA 21 CFR Part 11. It is important to note that compliance is an ongoing process, and therefore, organizations should regularly monitor and update their systems and policies to ensure adherence to the standards established by the FDA.

The platform was also designed following the applicable recommendations from NERC CIP, such as the CIP- 007-1-Cyber Security-System Management.

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES).

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

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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 password. They are encrypted before being stored.
Maximum and Minimum Age for Password: A feature that imposes a minimum password age before allowing its 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:

<<<<add info>>>>

Establishes minimum requirements for passwords.
Block on Invalid Login Attempt: Blocks User after reaching maximum number of invalid logins attempted.
Store Password History: A range of the last 0-5 passwords can be stored to make sure 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, set of records, that provide documentary evidence of the sequence of activities that have affected at any time a specific operation.

For detailed Explanation on how to add security management in project consist with these rules, go to the page FDA 21 CRT Compliance page, under the chapter Security, Users and Roles.

For addition information on NERC CIP-007-1 -Cyber Security-System Management, go to the page NERC CIP Overview.

Built-in .NET Security

The FactoryStudio FrameworX development is based built on the .NET , using managed code, following security guidelines, where the development with .NET managed code must follow the .NET rules. There are specific guidelines followed for specific modules. For example, the Alarms adherence to the FDA guidelines are followed, for Electrical device communications with the IEC61850, or the other IEC are followed. Below are the main FS-Security topics and some basic information about them.

Link to Microsoft information about Security in .Net:

https://docs.microsoft.com/en-us/dotnet/standard/security/

framework, following strict security protocols. Each module adheres to specific guidelines aligned with its function, such as FDA compliance for the Alarms module and adherence to standards like IEC61850 for modules handling electrical device communications.

Below are the main security topics along with essential details about each.

Tip

title	Security at the Core Level

Security

must be implemented

implementation is ingrained at the core

, not

level rather than being applied externally.

the Platform Moduleshave

The platform's modules incorporate built-in security

the core.

their very core.

For more detailed insights into security in .NET, refer to Microsoft's documentation available at: Microsoft .NET Security Information

Communication Security

Communication between modules

The cryptography Cryptography plays a crucial role in securing communication between external modules — processes out of TServer: and TServer, encompassing processes such as ScriptTaskServer, DataAccess, Devices, TRichClient, SmartClient, ModuleInfo, TraceWindow, PropertyWatch, etc — and TServer uses basically two classes:and PropertyWatch. Two primary classes are employed for this purpose:

a) System.Security.Cryptography.RSACryptoServiceProvider RSACryptoServiceProvider (Asymmetric, KeySize: 1024): Performs Facilitates asymmetric encryption and decryption using utilizing the RSA algorithm implementation of the RSA algorithm provided by the cryptographic service provider cryptographic service provider (CSP).

bb) SystemSystem.Security.Cryptography.Rijndael (KeySize: 256).

Note 1: No external program gets access to the TServer without

: Utilized for encryption and decryption, Rijndael operates with a key size of 256 bits.

It's essential to note:

External programs can only access TServer after undergoing validation/authentication. TServer

answers

responds to external

programs only after validation

requests only following validation/authentication

via

, accomplished either through user/password authentication or Windows Authentication.

Note 2:

"RSACryptoServiceProvider" is

used to generate "

utilized for generating private/public keys, while "

; "

Rijndael"

is used to encrypt/decrypt the data and it uses "

handles the encryption/decryption process, leveraging the aforementioned private/public keys

" described above

.

Note 3: The data are only compressed if block size is over 16000 bytes. The compression is GZIP". "ModuleInformation" displays estimated values of each connection. WCF adds some bytes while sending data, so the values in "ModuleInformation" are estimated.

Note 4:

Data compression is employed only if the block size exceeds 16000 bytes, utilizing the GZIP compression method. The ModuleInformation feature offers estimated values for each connection, considering that WCF may introduce additional bytes during data transmission.
".NET Framework applications should

use

utilize the TLS version supported by the operating system (OS)

supports

."

FS

FactoryStudio does not manually

set

configure the TLS

version using the configuration of the operating system (OS).Note 5: Remote access by

version but rather relies on the OS's configuration.
Remote access via WebAccess services (third-party

program

programs or modules)

will use http or https consuming the

utilizes either HTTP or HTTPS to consume available web services

available

.

Communication with web clients

HTML5

can use

provides flexibility in choosing between "http" or "https/ssl" protocols.

The compression will be configured on "IIS" and it will be GZIP".

Further, you can setup your application to have mandatory long, as well various forms with custom authorization, like IP filterer, or Location, among other.

Secure WebGateway

The TWebGateway is a tool included in the platform to allow to route data across different security Network zones, like moving that from the Level 2, the factoryFloor, to Level 4, the enterprise.

It also

You can configure compression settings like GZIP on the IIS server. Moreover, you can implement custom authorization methods such as IP filtering or location-based authentication, along with mandatory session settings.

Secure WebGateway

The TWebGateway is a crucial part of our platform, enabling smooth data transfer across different security network zones. It serves as a bridge, moving data from lower levels, like the factory floor (Level 2), to higher levels such as the enterprise (Level 4).

Acting as a protective barrier, the TWebGateway shields internal networks from insecure traffic. Enterprises rely on it to guard employees and users against potential threats from malicious web traffic, websites, viruses, and malware.

prevents unsecured traffic from entering an internal network of an organization. It is used by enterprises to protect their employees/users from accessing and being infected by malicious web traffic, websites and virus/malware.

Files and Execution Protection

License/Softkey

The "License/Softkey"

uses

feature employs the .NET class System.Security.Cryptography.Rijndael

(symmetric, KeySize: 256)

, utilizing symmetric encryption with a key size of 256 bits.

Digital signature

All assemblies created by Tatsoft are signed digitally.

Project format (Configuration protection)

All project

configuration is

settings, including security measures like cryptography, power recovery, and user/password protections, are stored in a relational database (.tproj file)

with all security and protections like cryptography, power recovery and Users/passwords

. The

Scripts and Displays have the

source code and

the

compiled binaries for Scripts and Displays are also stored in

the same .tproj

this file.

It makes the project easy to manage and deploy.

This centralized storage method streamlines project management and deployment, making access and maintenance easier.

User Authentication and Permissions

User Authentication

The Our platform supports Integration offers integration with various systems for user authentication:

Microsoft ActiveDirection, Widows

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Microsoft Active Directory and Windows Authentication

Connection with

LDAP server connection

Using the built

Built-in Users Database

Connection with external Databases or User Authentication

External databases or user authentication servers

Active-Directory / Windows Authentication

When using

Enabling Windows Authentication

,

bypasses the project

will not use the User list configured in the project, only the policies, and this management is controlled by Windows. The Windows User that is logged into the computer will be the one used in the system.

's configured user list, relying on Windows policies instead. Windows manages user authentication directly, utilizing the currently logged-in Windows user for system access.

LDAP

When

using

LDAP is used, the project

will not use the User list configured in the project, just the policies and this management is controlled by

ignores its configured user list and relies on policies managed by Windows and the LDAP Server. Authentication is handled by both Windows and the LDAP Server

. The External User that is logged in

, with the external user logged into the LDAP Server

will be the one used in the

being utilized within the system.

Runtime Users

Dynamically create

The system dynamically generates users and

store

stores their credentials in SQL databases.

Get users from Active-

It seamlessly integrates with Active Directory or third-party

system for

systems to retrieve users, enabling integrated security

or

and unified login capabilities.

Roles, Permission and Policies

Group and User Permissions

Total

Our users have complete flexibility to define privileges based on groups or specific

users

individuals. Permissions can be

global

set globally or

tied to a specific display, object

linked to particular displays, objects, or input

action

actions, offering granular control over access levels.

User Policies

Identification

Our platform offers a comprehensive array of user management features, including identification policies, session duration

,

control, automated logoff

, e-sign,

mechanisms, electronic signature capabilities, and robust audit-trail

, and a complete set of user management features are available.

functionality.

Database Injection Protection

In the database, calling Stored Procedure, there is a great concern about this part of "injection", because if parameters are passed as plain text in SQL Statement, the "injection" could be possible. Against this we use the .NET API where parameters are added to a list, making it impossible to code injection.

Security External Validation

Regularly the platform is accessed by Veracode, or third-party companies, on penetration testing report, gap analysis, and various other topics.

Any issues that would prevent a 100% approval are corrected.

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