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How to Track Regulatory Correspondence in Kivo

Written by Jianna Lieberman | Aug 22, 2024 8:56:35 PM

Tracking agency commitments is essential for obvious reasons, but can be stressful without a system or process to manage them. With Kivo's Correspondence Tracking, you'll never have to worry things are falling through the cracks. Let's take a look at how it works! 

To start, we'll navigate to Regulatory Activity.

There are many types of Regulatory Activities that you can log in Kivo, including Applications, Submissions, and Products. But for this article, we'll select Correspondence

Once you select the Subtype, you'll add a description. Kivo will automatically create the formatted name based on your SOPs. Click "Create"! 

Once you've created the activity, you can enter all the relevant information & metadata such as the Health Authority, the point of contact, the Related Application, and Due Date. But that's not all! Each piece of correspondence has to be logged in the DMS, so let's do that next.  

Scrolling down, you'll see a Related Content section. (You can also associate the Correspondence with a Project, such as an IND or CAPA, but we'll skip that for now.) This is where the magic happens. Click on "Add to Cabinet" and Kivo will automatically create the folders and document placeholders for your correspondence

Here's what that looks like once you Add to Cabinet. And each of these links directly to the document and placeholder in the DMS!

 With a simple drag and drop, you can add the source file of the email (including attachments!), and then view it at any time by clicking on Source.  

Finally, you can use all the metadata you added to track your correspondence in the Correspondence Log! You can access the log from the Reports module. You can filter by ApplicationAuthority, or Due Date, and you can schedule delivery of the report to your inbox with a couple clicks! 

TL;DR: never stress about missing a response again. And build an inspection-ready audit log while you're at it.

All thanks to a little auto-magic 🔮🪄✨

Anyhow, check out our full suite of regulatory capabilities in our clickthrough demo here. And if you'd like to learn more about how Kivo can help reduce manual tracking for you and your team, get in touch!