Why does 32 Karat software allow multiple e-signatures across a single data set?

For research use only. Not for use in diagnostic procedures.

Answer

This was designed to enable 32 Karat software flexibility to fit into different quality control environments. 32 Karat software provides 21 CFR P11 tools and features. However, 21 CFR P11 compliance depends on coordination with your organization’s quality and compliance policies.

The electronic signature feature in 32 Karat software supports multiple users and allows individual users to sign multiple times. All signatures are recorded, and signatures cannot be revoked unless done so by a user with equal or higher signature privileges. 32 Karat software has default reasons that can be selected as reasons when signing, and custom reasons can be added by the system administrator. A single user may need to sign for multiple reasons, such as signing as an author or approving the data as a reviewer.  Each user may need to sign for different reasons or different roles.

Define Electronic Signature users and reasons

1. Log in to 32 Karat software and navigate to Tools -> Enterprise Login.

2. Enter the username and password.

3. Navigate to Tools -> System Administration Wizard.

4. Select Project and select Next.

5. Select Change a project’s settings and select Next.

6. Click Next until you reach Define Electronic Signature Roles.

7. Select Modify to edit the Electronic Signature response.

8. In the Reason to be added field, enter a new reason and select Add.

9. Click OK and click Finish.

Remove a user’s access for Electronic Signatures

1. Log into 32 Karat software and navigate to Tools -> Enterprise Login.

2. Enter the username and password.

3. Navigate to Tools -> System Administration Wizard.

4. Select User and select Next.

5. Select the user to edit and select Next.

6. Click Next until you reach the Set User Privileges window.

7. In the Selected projects pane, select the project.

8. In the Assigned privileges pane, select Electronic Signature and select the red arrow to move Electronic Signature to the Unassigned privileges pane. This removes the Electronic Signature access.

9. Repeat steps 7-8 for any other projects that will be restricted for this user and click Next.

10. In the Set User Electronic Signature Role, set the role desired for this user.

11. Click Finish.