Resource Library
Your one-stop-shop for regulatory, clinical, and quality insights, from whitepapers to webinars to how to guides.
Best QMS Software for Managing SOPs & CAPA
What QMS Software Is Best for Managing SOPs and CAPA in a Small Biotech?
Kivo Joins Experts at RAPS San Francisco to Report on Real-World AI Use Cases in Life Sciences
Kivo Joins Experts at RAPS San Francisco to Report on Real-World AI Use Cases in Life Sciences
How To Manage Part 11 Compliance With No IT Team
How do I manage Part 11 compliant document control without a large IT team?
Half of Newly Developed Drugs Are The Result of This 1983 Law
"Orphan" drugs were once a market almost no company wanted. Four decades later, they make up more than half of the new drugs the FDA approves.
What's The Best QMS When Preparing For An FDA Inspection?
Last Updated: September 2026
What's the best QMS for a team preparing for an FDA inspection?
How to Choose a GMP QMS for Small Pharma in 2026
If you're leading quality, regulatory, or clinical operations at an emerging pharma or biotech sponsor, you've likely felt the tension between staying agile and maintaining GMP compliance....
Why America's drug shortages are lasting longer
Ask two trusted sources how bad America's drug shortage problem is, and you get two answers that seem to come from different countries.
10 Features Every Biotech QMS Should Include
Last Updated: October 2026
What features should a biotech QMS include?
At a minimum, a life sciences QMS should include controlled document management, Part 11-compliant electronic...
What is a QMS in life sciences?
What is a QMS in the life sciences industry?
A quality management system (QMS) in life sciences is a structured framework of processes and controlled documentation that pharmaceutical,...
What QMS Can You Implement Without a Dedicated IT Team?
Last Updated: September 2026
What QMS can you implement without a dedicated IT team? A cloud-native quality management system built specifically for life sciences and pre-validated by the...
Kivo and CRISPR Therapeutics to Present 52-Day QMS Modernization at DIA 2026 in Philadelphia
Kivo and CRISPR Therapeutics to Present 52-Day QMS Modernization at DIA 2026 in Philadelphia
The Top 5 Diseases Affecting Men (And The Clinical Trials Racing To Treat Them)
Every year on Father's Day, we celebrate the dads in our lives. But American men are, statistically, working against the odds.

