Historian in a Regulated Environment

Many FDA-regulated industries are required by the United States government to be compliant with regulations such as the 21CFR Part 11 regulation. If your industry is one of them, you will need software that allows you to build a compliant application or process. The flexibility and versatility of Historian lets you create a compliant process by:
  • Providing limited system access to authorized individuals.
  • Adding a timestamp to annotations, and displaying timestamps from the Historian archive.
  • Requiring electronic signatures on annotations.
    Note: This option is available if the Electronic Signatures/Records option is enabled in the Historian Server.
  • Supporting human-readable printouts and computer-readable format for audits (by exporting data to a CSV file that can be imported to a Microsoft Excel document or an SQL database).

Disabling Guest Accounts for a 21 CFR Part 11-Compliant Environment

If you want to use Historian in a 21 CFR Part 11-compliant environment, make sure that you disable guest accounts on your computer. This action applies whether or not you use Historian security.

Compliant Parameter Settings

You can set the following 21 CFR 11-compliant parameters in the Security section of the Data Store page.
Field Description
Require Point Verification Indicates whether you must enter identifying information whenever you attempt a restricted action. Whenever you attempt to change the system configuration (for the tag, archive, or collector), a tag value, or another record, you must electronically sign the action with a username and password. If the user is authorized to make this change, the identity of the person, the action performed, and the time it was performed, are all recorded in the audit trail.
Note:
  • The audit features are not dependent on this feature being enabled. Historian audits all user actions regardless of whether this option is enabled.
  • If you plan to create multiple archives at the same time, select the Disabled option.
Enabling electronic signatures and electronic records also requires you to reverify your identity when you use the Historian Excel add-in, modify or create a tag, or import data or messages.
Note: This feature is available only if you have purchased the Electronic Signatures and Electronic Records option.
Verification Message When point verification is enabled, you are prompted to enter the username and password whenever you attempt to perform an action specified as requiring point verification.