Research and Compliance Modes

GemStone can be set up to run in either a Research-Use-Only mode or in Compliance mode. When the program is in Compliance mode, you have the ability to control which users can do different operations.  Here are some differences between RUO and Compliance modes:

• Compliance mode makes use of your operating system's 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 program 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 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 analysis engine.

The program displays the mode of operation in the upper right corner of the ribbon:

 or  

Set Up Research Use Only Mode

After initial installation, GemStone will automatically be in Research (RUO) mode. No further configuration is 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.

Set Up Compliance Mode

Setting up Compliance mode 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 GemStone 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 GemStone in Compliance mode helps you with 21 CFR Part 11 compliance. Click here for details.