Research and Compliance Modes

ModFit LT can be set up to run in either a Research-Use-Only mode, or in Compliance mode. There are some differences in how the program operates in each mode.

• Compliance mode depends on operating system user groups to control the level of access to program features. Research mode allows any user to perform any operation.
• Compliance mode displays a login dialog when the ModFit LT is starting up to verify the user and determine the group to which the user belongs.
• Compliance mode enables logging so that there is a record of the activities of each user. Research mode can be run with logging enabled or disabled.
• Compliance mode is designed to support clinical labs and can be part of a compliance plan for the US-FDA's 21 CFR Part 11 regulations. Research mode does not provide compliance with 21 CFR Part 11.
• Both modes use the same intuitive interface and ModFit LT engine.

The program displays which mode it is operating in.  In the Ribbon bar interface, the mode is displayed in the upper right corner of the ribbon:

 or  

In the Toolbar interface, the mode is displayed on the main toolbar next to the Help button.

Setting Up Research Use Only Mode

After initial installation, ModFit LT will automatically be in Research mode. There is no further configuration required.

To revert to Research mode after setting up Compliance mode, the user groups that were created for Compliance mode must be removed. Once the user groups are removed, the program will revert to Research mode.

Setting Up Compliance Mode

Setting up Compliance mode is something that should be performed by IT personnel.

While it is not a complicated task, it requires administrative access rights and a clear understanding of user groups and permissions. It is therefore something that we strongly recommend be performed by the IT team at your institution. The task involves creating several required ModFit LT user groups for your computer or domain, and then adding users to those groups. Once the groups are defined, the program automatically operates in Compliance mode. Click here for details.

21 CFR Part 11 Compliance Matrix

This matrix provides a simple summary of how ModFit LT in Compliance mode helps you with 21 CFR Part 11 compliance. Click here for details.