Combination products represent some of the most innovative therapies in life sciences, but they're also some of the most complex to develop, manufacture, and bring to market.

Vendor oversight is a regulatory requirement that comes with some tough challenges.

Quality events in life sciences aren’t just routine compliance tasks.

They’re pivotal moments, and when they're handled well, they can accelerate development and build trust. Handled...

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...

As regulatory requirements become increasingly stringent in the pharmaceutical and medical device industries, companies must adopt efficient, scalable, and compliant solutions to manage...

Maintaining high standards of quality and safety in life sciences industries is essential. Several globally recognized quality management systems have been established to ensure...

Establishing a compliant quality foundation can be a struggle for many small to mid-sized organizations...where do you start? How do you manage rollout? How do you create processes that are...

So what is a CAPA anyway?! This article will outline everything you need to know about this common Quality process. Much of this article focuses on CAPAs in a medical device context, but...

It's easy to create and manage training courses and materials in Kivo - and use reports to track compliance. Let's see how it works!

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...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, or simply ICH, stands as a cornerstone in the realm of pharmaceutical development...

Happy new year folks!