The Challenge
Talosix had a compliance problem. An audit was right around the corner - two weeks later, in fact. A consultant they hired flagged that their current documentation and processes (a combination of Sharepoint, Excel, and Word docs) wasn't going to meet the standards of the FDA. Talosix needed a compliant solution FAST.
As the VP of Product stated, "Our top priority is compliance. We need something validated, with part-11 compliance built in, that an inspector can easily navigate – and we have an extremely tight timeline to get this done. And long-term, we need to create standardized, repeatable processes that we can scale.
"In the past, we've been focused on real world evidence studies. But we are entering Phase 2 & 3 trials that require increased compliance. We haven’t had to deal with FDA audits at this level before.
"Our existing process with SharePoint, spreadsheets and Word docs is a big mess. It’s not organized. And the first thing our consultant said was that it wouldn’t pass muster with the FDA."
"It’s only going to get harder as we grow. The longer we keep going this way, the more work we are going to have to redo."
Talosix needed a system right away, but also needed a long-term solution that could grow with them. Enter Kivo!
The Solution
On the recommendation of their consultant, Talosix came to Kivo to see what was possible. In the first call, the team was able to see the benefits of the system.
"The benefits of having a platform where things are more structured is obvious. We can track training logs. Document history and SOPs are in a templated format, as are the working instructions, and everything is linked together."
At the same time, the team had experience with other Quality Management Systems that required dedicated resources to manage. With Kivo, however, the smartly automated features eliminated the need for those types of resources.
Given the impending deadline, we started the implementation right away, starting with the core DMS using our out-of-the-box configuration. We provided them with our quality activity and vendor forms, which they adapted to their business processes. Once we had them ready for their audit, we started adding on eTMF, which went live in another two weeks. Finally, we worked hand-in-hand with the Talosix team to implement Quality Activities and Vendor processes.
"I didn't think it was possible to get up and running in two weeks!"
The Results
Talosix was able to successfully meet their tight timeline and prepare for their FDA audit. Post audit, they have continued to expand their engagement with Kivo, more than doubling their use of the system, as well as increasing the number of trials under management.
