21 CFR Part 11 Compliance Checklist
Meeting 21 CFR Part 11 requirements is a critical concern for teams managing electronic records and signatures in FDA-regulated environments.
The Role of Virtual Data Rooms in Drug & Device Development
In biotech, the term "virtual data room" often conjures images of fundraising diligence: a static folder of key documents used to satisfy investors or legal teams during a transaction. But...
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.
The Future of eQMS: How Automation is Changing Compliance and Quality
As regulatory requirements become increasingly stringent in the pharmaceutical and medical device industries, companies must adopt efficient, scalable, and compliant solutions to manage...
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...
What's Good in QC? Understanding Quality Control and Compliance Standards: GQC, GMP, GLP, GCP, and GDP
Maintaining high standards of quality and safety in life sciences industries is essential. Several globally recognized quality management systems have been established to ensure...
Quality Made Simple: Getting Started with QMS
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...
Kivo April 2024: Biotech Jobs, Mergers, and Auto-Fill Quality Forms
The past month has been a fun one! We had over 200 people tune in for a TMF panel discussion (recording link below) and got to hear all about eclipse totality from our many east coast...
Kivo March 2024: Biopharma Funding, RWD EU Updates & eCTD Linking
Welcome to a new monthly newsletter from Kivo! We know you get lots of newsletters, so we want to ensure this is valuable for you! If you'd like to receive this newsletter in your inbox, ...
What is CAPA in Clinical Trial Research?
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...
Toban Zolman joins Steve Gens to discuss Kivo's rapid growth
In this episode of the Gens & Associates Podcast, Kivo CEO Toban Zolman joins managing partner Steve Gens to discuss Kivo's success with smaller stage life science companies, Kivo's process...