The Complete Guide To Correspondence Management In Life Sciences
In life sciences, it's easy to overlook correspondence. Between protocols, submissions, validation plans, and controlled documents, emails and message threads can feel like background...
Regulatory Document Management Systems Explained
SOP drift. Duplicate files. Missed periodic reviews. Failed audits. These are all symptoms of a document management process that isn't built for regulatory rigor.
A Helpful Guide To The Regulatory Submission Process
The regulatory submission process is an important, if complex, part of bringing a new product to market.
All About 21 CFR Part 11 Compliance
What is 21 CFR Part 11?
21 CFR Part 11 is a regulation established by the U.S. Food and Drug Administration (FDA) that sets the criteria for electronic records and electronic signatures...
RIM Explained: Regulatory Information Management & Systems
Regulatory information management (RIM) is not just a compliance task to cross off your preclinical checklist.
EU MDR vs. FDA Regulations: Key Differences
Introduction to Regulations
Medical device manufacturers operating in both the European Union and the United States must comply with two distinct regulatory frameworks: the European Union...
How to Track Regulatory Correspondence in Kivo
Tracking agency commitments is essential for obvious reasons, but can be stressful without a system or process to manage them. With Kivo'sCorrespondence Tracking,you'll never have to...
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 Projects Efficiently with Automated Reporting
One of the more challenging aspects of clinical trial management is visibility. The sheer number of outsourced partners - sites, CROs, writers, consultants, vendors, etc - who often have...
A Guide to Regulatory Submissions in the US (FDA) & EU (EMA)
If you're new to regulatory submissions, they can seem a little confusing - and not just because there are some many acronyms to learn. To help you navigate the landscape, we offer this...