Setting compliance project options

If electronic signatures are enabled, users are required to enter an electronic signature and optional change reason when an item is created, modified, or deleted. You can specify the maximum number of attempts users have to enter the correct electronic signature password before they are automatically logged out and a certification message to display with the electronic signature to meet compliance requirements.

Note:  See Setting item compliance project options for information about enabling electronic signatures.

1. Choose Tools > Administration > Project Options.

The Project Options dialog box opens.

2. Select the Compliance category.

3. Select the Maximum attempts before logging out a user to specify the number of attempts users have to enter the correct electronic signature password before they are automatically logged out. Any unsaved changes are discarded when the user is logged out.

4. Enter a Certification and testimony message to display in the Signature Required dialog box.

This read-only message is displayed in the dialog box to explain the purpose of the signature, which is required for FDA Part 11.100 Subpart C Paragraph 2 compliance.

5. Click OK to save the changes.