Document authoring is one of the most essential activities in Regulatory, Clinical, and Quality operations. Regulations such as CFR Part 11 requiring compliant e-Signatures dictate the way in which documents must be approved. If documents are not handled in a compliant way, it can create issues down the line that may delay regulatory approval. The sooner you can get your documents into a fully validated system with a compliant approval process, the better!
With this in mind, let's review (pun intended) the Review and Approval flow in Kivo GO.
Let's say that you are working on a protocol document. After you have collaborated with teammates to get to a final version, you'll be able to Convert to PDF and then route for Review. You can also skip the PDF step if it's not needed.
You can select multiple reviewers or just one, and leave a note with instructions. Each reviewer will then receive an email letting them know about the new assignment, as well as see the task on their Kivo homepage. When you're ready, click Route.
Reviewers can choose to Accept or Reject the document. If it's rejected, the reviewer will need to input the reason for rejections. This is an easy way to see the whole team's review status at a glance.
For our purposes, let's assume the protocol passes review. Now we are ready to Route for Approval! There are two different approval options in Kivo; Simple Approval and Part-11 Compliant "Sign & Approve" with Docusign.
When approving a document, the Reviewer will select why they are approving (or rejecting) the document. The list of reasons can be configured to match your workflows. Once the reason is selected, hit Approve!
And that's it! Once the document is approved, it will be locked from future changes. If you are leveraging Projects with task automation, any tasks that are waiting on this document will be marked as complete.
How cool is that?!
For a quick overview of our full Regulatory capabilities, check out this click-through demo. Happy authoring!!
