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 the life sciences industry?

A quality management system (QMS) in life sciences is a structured framework of processes and controlled documentation that pharmaceutical,...

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

Every year on Father's Day, we celebrate the dads in our lives. But American men are, statistically, working against the odds.

If you work in pharmaceuticals, biotechnology, or medical devices, you have likely encountered the term TQM at some point. It shows up in regulatory guidance, quality audits, and industry...

Biotech is one of the most exciting and most demanding industries in the world. It's where cutting-edge science meets real-world medicine, where small teams with bold ideas chase cures that...

If you've ever been on the receiving end of an FDA inspection, you know the moment the investigator asks for your Device History Records. Everything stops. Your team scrambles. Someone...

For regulated life sciences teams, demonstrating compliance isn't optional, and a declaration of conformity is one of the most important documents in your compliance toolkit. Whether you're...

Last Updated: October 2026

For emerging pharma and biotech teams, few distinctions matter more or get blurred more often than the difference between quality assurance and quality control....

Nearly 3 in 10 American adults report skipping medications because they cost too much.