Historian in Regulated Environments

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.
  • Time-stamping annotations when saved, and displaying existing time stamps from the Historian archive.
  • Requiring electronic signatures on annotations if the Electronic Signatures/Records option is enabled in the Historian Server.
  • Enabling human-readable printouts (using the Print command) and computer-readable format (by exporting data to a CSV file that can by imported into Excel or an SQL database) of audits.
The Electronic Signatures and Record options of Historian allow you to keep an auditable trail of most Historian functions. Although this feature is designed primarily for FDA-regulated industries, any application that requires or could benefit from audited trails can make use of its features.

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

The 21 CFR 11-compliant parameters you can set from the Security tab of the Data Store Maintenance screen are:
Table 1. Parameter Settings
FieldDescription
Require Point Verification (Enable/Disable) If you select Enable, Historian requires you to 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 other 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.
Enabling Electronic Signatures and Electronic Records also requires you to reverify your identity when you use the Excel Add-In, to 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, a message request for username and password appears whenever you attempt to perform an action specified as requiring point verification.

Example

When you click Update on the Security tab following an attempt to change the status of the Point Verification feature, or when you attempt to perform an action requiring point verification, the dialog box shown in the following figure appears.

Enter your Username, Password, and Domain in the appropriate fields and then click OK to proceed.