Note: ZenSign is a paid service. If interested, please reach out to the ZenQMS Help Desk as help@zenqms.com for more information.
ZenSign for the Documents Module offers a compelling alternative to traditional e-signature solutions like Docusign and AdobeSign. Unlike its costly counterparts, ZenSign eliminates the need for expensive Part 11 compliant versions and avoids the "paper on glass" approach. Crucially, it streamlines operations by leveraging existing validations (you're likely already validated for Part 11 compliance!), allowing for easy configuration and activation at the category/workflow layer.
ZenSign makes signing easy for everyone: any authorized user can kick off a workflow, and anyone with an email can sign. Your important documents stay secure within ZenQMS – they never leave our trusted, closed system, backed by a built-in X.509 certificate. No more separate software to validate, no more frustrating monthly license fees for every author. ZenSign is designed for efficiency, security, and true ease of use, making it the clear choice for your electronic signature needs.
Activating ZenSign in Account
Click on 'Settings >Active Modules'. Toggle on the ZenSign option.
Setting ZenQMS Steps in Document Category
Click on 'Settings >Document Categories'. You will need to create a new category or upversion a current document category so that it is in a draft state to update the workflow steps. Open the category's settings and click the 'Manage' button on any workflow that you would like to add a ZenSign step to.
Click on 'Add Step'.
Give the step a name, select 'Needs to Sign' for action type, add a signature reason, and toggle on the option for ZenSign. You can also configure the step to require a comment, and/or always be last.
Sending a Signature off with ZenSign
Note: The journey shown below is using the Approval - Major Revision workflow as an example. The functionality works the same, no matter which workflow the ZenSign steps are in.
Open the document that is in the category configured for ZenSign. Once ready, send the document through the workflow. Once the slider box opens to select the workflow participants, add the external approvers information (name and email address).
It is important to note that if you need to add an 'Ad Hoc' signature, you may also set this signature up for ZenSign as the account has ZenSign enabled already. Once all the information is filled in, launch the document off for approval.
The external user will get an email notification from ZenSign like the one shown below. Please make sure that the email address noreply@zensign.co is on the email whitelist. The user will need to click the 'Review and Sign' option to start the process.
A box will pop up asking for the external user's email address, again. Once they enter their email address, ZenSign will send a code to their email inbox. The user will need to enter the code that was emailed to them.
After entering the code, they will need to accept the e-disclosure. Aftering accepting, the item will show for the user. The external user can view the document on the left; on the right lists the workflow steps, which shows the ZenSign step being the current step, as well as an 'Approve' or 'Reject' button.
Approving a Document
If the external user approves the document, they will click 'Approve'. A slider will open and the user will need to enter the following highlighted information. The code that they will enter is the same code that was originally sent to their email address. If needed, they may click on the option to resend the code to their email. Click 'Submit Electronic Signature' when completed.
After the signature is submitted successfully, they will see a success banner to the right with a button to view the document.
The external user will be able to see the same screen as they did when signing, but now their signature has been submitted and can be seen on the right side.
The external user will get one last email that provides a link to the completed document. The email will list the end date the external user has to view the document.
Rejecting a Document
If the external user clicks 'Reject', a similar slider box will appear where they will need to enter their information, but now, the comment section is required. The will click the 'Submit Electronic Signature' option when ready.
After the signature is submitted successfully, they will see a rejection banner to the right with a button to view the document. Depending on the author's notification settings, they will get an email stating that the document was rejected.
The external user will be able to see the same screen as they did when signing, but now their signature has been submitted and can be seen on the right side.
The author of the document can see that the signature was rejected at the document level. They can review the comments that were left from the external user by clicking the 'Workflows/Signatures' option. The workflow will need be cancelled to make the necessary changes. Once the changes are made, the document can be sent out for approval again.
Note: Users will need the role permission 'ZenSign: External Assignments' to set up a ZenSign approval step in a document category.