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Security policies allow administrators to configure user identification, e-signature, and session management settings to ensure security compliance. The purpose is to define and enforce security rules. Main functionalities include setting password requirements, enabling e-signatures, and controlling session timeouts. Applications involve creating policies for user access control in solution environments.

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Configuring Policies

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

Pre-defined Policies

The platform comes with a few predefined policies that you can use, or you can create your own.

  • Default

  • Enhanced

  • Critical

Policies (Reference) enforce password requirements, electronic signatures, and session management rules for regulatory compliance and security best practices. 

ecurity Policies provide:

  • Password complexity requirements
  • Electronic signature validation
  • Session timeout management
  • Account lockout rules
  • Password aging controls

Policies enable FDA 21 CFR Part 11 compliance and other regulatory requirements.


Pre-Defined Policies

Three standard policies are configured:

PolicyUse CaseTypical Settings
DefaultStandard operationsBasic password, no timeout
EnhancedElevated securityComplex password, session timeout
CriticalRegulatory complianceStrong password, e-signature, strict timeout

Configuration Properties

PropertyDescriptionRequired
NameUnique policy identifierYes
IdentificationPassword and account rulesYes
ESignElectronic signature settingsNo
SessionTimeout and auto-logoffNo
DescriptionDocumentation textNo

Identification Settings

Password and account management rules:

Password Requirements

PropertyDescriptionRangeDefault
PasswordMinLengthMinimum characters0-1280 (no limit)
PasswordHistoryPrevious passwords to remember0-50
MinPasswordAgeHours before change allowed0+0
MaxPasswordAgeHours until expiration0+0 (never)

Account Security

PropertyDescriptionRangeDefault
UserNameMinLengthMinimum username length0-1280
BlockOnInvalidAttemptsFailed logins before lockout0+0 (no limit)
BlockAgingHours until auto-unlock0+0 (manual)
AllowPasswordChangeUsers can change own passwordYes/NoYes
AllowShareUserMultiple concurrent sessionsYes/NoYes

E-Signature Settings

Electronic signature requirements for critical actions:

PropertyDescriptionUse Case
EnabledRequire e-signatureFDA compliance
TimeoutMinutesSignature validity periodRe-authentication frequency

Configuring E-Signature

  1. Enable in policy settings
  2. Set timeout (e.g., 60 minutes)
  3. Assign policy to users
  4. Enable on controls requiring signature

Example:

csharp

// Check if e-signature required
if (@Security.Policy.ESign.Enabled)
{
    // Prompt for password
    if (!@Security.ValidateESignature())
    {
        return; // Action cancelled
    }
}

Session Management

Automatic logoff configuration:

PropertyDescriptionOptions
AutoLogOffLogoff triggerNone, Inactivity, Duration, Both
InactivityMinutesIdle time before logoff1-9999
DurationHoursMaximum session length1-9999

AutoLogOff Modes

ModeBehaviorUse Case
NoneNo automatic logoffDedicated stations
InactivityLogoff after idle timeShared workstations
DurationLogoff after time limitShift changes
BothEither condition triggersMaximum security

Applying Policies

Assign to Users

  1. Navigate to Security → Users
  2. Select user row
  3. Set Policy column
  4. User inherits all policy settings

Runtime Behavior

csharp

// Get current user's policy
string policyName = @Security.CurrentUser.Policy;

// Check policy settings
var policy = @Security.Policies[policyName];
bool requiresESign = policy.ESign.Enabled;
int passwordMinLength = policy.Identification.PasswordMinLength;

Compliance Scenarios

FDA 21 CFR Part 11

Policy: Critical
Identification:
  - PasswordMinLength: 8
  - PasswordHistory: 5
  - MaxPasswordAge: 2160 (90 days)
  - BlockOnInvalidAttempts: 3
ESign:
  - Enabled: True
  - TimeoutMinutes: 30
Session:
  - AutoLogOff: Both
  - InactivityMinutes: 15
  - DurationHours: 12

High Security Environment

Policy: Enhanced
Identification:
  - PasswordMinLength: 12
  - AllowShareUser: False
  - BlockOnInvalidAttempts: 5
  - BlockAging: 24
Session:
  - AutoLogOff: Inactivity
  - InactivityMinutes: 10

Best Practices

  1. Start with pre-defined - Modify existing policies
  2. Document requirements - Clear compliance needs
  3. Test thoroughly - Verify all settings work
  4. Train users - Explain policy changes
  5. Regular reviews - Update as needed
  6. Gradual implementation - Phase in restrictions
  7. Monitor compliance - Track violations

Troubleshooting

Account locked:

  • Check BlockOnInvalidAttempts
  • Verify BlockAging timeout
  • Administrator unlock required
  • Review failed login attempts

Password rejected:

  • Check PasswordMinLength
  • Verify against PasswordHistory
  • Confirm MinPasswordAge not violated
  • Review complexity requirements

Unexpected logoff:

  • Check Session settings
  • Verify InactivityMinutes
  • Review DurationHours
  • Check client activity detection

E-signature issues:

  • Verify policy enabled
  • Check timeout not expired
  • Confirm user has password
  • Test signature validation

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Security Policies Properties Overview

Column

Description

Name

Enter a name for the policy. The system allows you to know if the name is not valid.

Identification

Select the password rules for both editing a project and accessing the runtime.

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Esign

For runtime only. Select to enable a timeout for the runtime login. Enter the timeout period in minutes.

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Session

For runtime only. Use to enable a timeout for the runtime session. Select what will cause an automatic logoff, then enter the appropriate values for InactivityMinutes and DurationHours. This setting only logs the user off. The application continues to run.

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Description

Enter a description for the policy.

AnchorIdentificationPropertiesIdentificationProperties

Identification Properties

Contains several password configuration options, detailed below:

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Security Identification Properties

Property

Description

AllowPasswordChange

Indicates if a user, other than an administrator, can change its own password.

PasswordMinLength

Minimum character length for password (0 means no restrictions).

BlockOnInvalidAttempts

Maximum number of login attempts before blocking user (0 means no restrictions).

AllowShareUser

Indicates if user can be shared between stations.

UserNameMinLength

Minimum character length for username (0 means no restrictions).

PasswordHistory

Remember last passwords (Range: 0-5).

MinPasswordAge

Minimum password age in hours (0 means no restrictions).

MaxPasswordAge

Maximum password age in hours (0 means no restrictions).

BlockAging

Maximum blocking age in hours (0 means no restrictions).

AnchorEsignPropertiesEsignProperties

Esign properties

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

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Security Esign properties

Property

Description

Enabled

Password will be requested for Action Dynamics with eSign is enabled.

TimeoutMinutes

Timeout  in minutes for password with eSign to remain valid.

Tip
titleStep by Step Esign

Configure the Security > Policies > ESign, enable and set the TimeoutMinutes (e.g.: 1 min). Then, in the Security > Users, set the configured Policy for the User you want. So, open the Draw section, double click in any TextBox object and enable the Security dynamic, now check the ESign required checkbox. Save and Run. Then, log in with the User you set up the configured Policy, and when the timeout minutes expire one dialog to entry the password will appears.

Session properties

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

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Security Session Properties

Property

Description

AutoLogOff

  • None

  • Inactivity

  • Duration

  • Both

InactivityMinutes

Inactivity Time (in minutes).

DurationHours

Inactivity Time 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.

Properties Reference

The Properties References present a reference that describes and explains the properties for Security Policies. The table lists all properties available for the configuration item. However, not all properties described in the documentation are displayed in the data grids by default. Right-click column headers to see which property columns are currently displaying. The displayed properties appear with a check mark.

The data grids allow users to manage and organize information by showing or hiding properties in tables within configuration interfaces. Users can view and select properties via column headers, enable multiple selections, add or remove columns, or reset grid settings. These features are available in all configuration interfaces using a table for data management. To turn on or off showing a property on the data grid, right-click column headers to select properties or use the reset button to return to default settings. Check out Working with DataGrids for detailed info.

Security Policies

Property

Description

ID

Identifies uniquely the policy record.

VersionID

Specifies the version of the policy.

Name

Names the policy.

Identification

Defines password and username requirements: Allows password change, sets minimum password length, blocks on invalid attempts, allows shared user, sets minimum username length, manages password history, sets minimum and maximum password age, blocks aging.

ESign

Enables or disables e-signature settings and sets the timeout for it.

Session

Determines session control settings: Sets AutoLogOff options (None, Inactive, Duration, or Both), and configures InactivityMinutes and DurationHours.

DateCreated

Records the date when the policy record was created.

DateModified

Notes the date when the policy record was last modified.

Description

Describes the purpose or details of the policy.

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