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 Security Add-On Module
Knowledge protection and data security do have increasing priority in all business areas. This also applies to spectroscopic data even in highly regulated environments like pharmaceutical industry. Special requirements from quality assurance department, FDA or GXP need to be met and addressed in every day work.
The Security Add-On module provides enhanced features to help you fulfilling such regulations easily. The module assists you controlling your workflows, protecting your knowledge and securing your accompanying spectroscopic data.
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Features at a glance
A fully configurable set of features is available as listed below. All features can be enabled or disabled on demand depending on your preferred security level:
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Wizard guided configuration of the Security Add-On module
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Standalone or LDAP based user management with wizard guided configuration
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User authentication on software start-up
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Automatic lockout after idle time
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Lock screen function
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Support for various password policies
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User dependent control over software functions utilizing permission schemes
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Workflow oriented, hierarchical data access control with distinct release policies
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Electronic signatures with predefined and custom release comments
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Data versioning
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Comprehensive activity log for data and software activities
Some features are described in more detail below.
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User Management and Login
Software access is controlled by an independent or MS-Windows based user management. Authorized users can be administered by an administrator user. Configurable permission schemes are applied to each user granting access to distinct software functions. During start-up of the software a login dialog is shown similar to Windows logon. After successful login the software only shows menus and functions the current user is permitted to use. |
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Data Access Roles
In parallel to the permission schemes users can also be assigned data access roles. These roles control, whether the current user is permitted to open, modify, copy or delete data. Multiple data access roles with particular data access permissions can be defined for user groups in your company like lab operators, lab supervisors, chemists, QA managers, etc. Data access roles are configurable and can be organized hierarchically according to your company hierarchy. Data can be transferred from one to another data access level by electronic signature. Signed data has the access permissions defined for the target data access role.
Example: The lab operator measures a spectrum and releases the spectrum by signing it. The lab supervisor will pick up the spectrum to create a calibration model. After a spectrum is in use for calibration both the spectrum and calibration model shall not be modified by the lab operator anymore. Hence the lab supervisor signs both to prevent lab operators to modify them.
Activity Logging
All activities like logon, log off, changing options, creating, modifying or removing data, etc. are logged in a comprehensive activity report. The report can be investigated by the administrator user in report viewer utilizing enhanced filter functions. The activity log helps you to track various operations being of interest during a company audit.
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