How to Review and Approved Controlled Documents in Kivo
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...
How to Manage Regulatory Projects and Content Plans in Kivo
Regulatory content planning is a foundational step for any regulatory submission. A regulatory content plan is a outline of the pieces of content required for the submission, their due...
Accelerate Quality Operations with Automatic Quality Templates
Quality operations, by definition, follow repeatable processes. Therefore, finding small-but-meaningful ways to accelerate these processes can add up to large time savings over time, and...
How to Link Documents Directly to your eCTD Submission
Imagine you have assembled your regulatory submission after months (or even years!) of effort. It is now time to send it to a publisher to compile into the correct format for submission to...