B3 Quality Consulting, LLC

Happy New Year from the team at B3 Quality! 🎊 As we step into 2025, we want to express our sincere gratitude to our clients, partners and team for an incredible year. Your trust, collaboration and commitment have been the driving force behind B3's growth and success. This new year brings new opportunities and fresh perspectives, and we're excited to continue delivering Right-Sized Quality solutions to support our clients on their journeys to success. Here's to a prosperous and inspiring 2025! 🚀 #HappyNewYear #2025Vision #QualityConsulting #RightSizedQuality

A client asked me this week, "Why do we need to validate our system (eQMS) if the vendor says it's already validated?" Is it ok to rely 100% on a software vendor's validation without doing anything yourselves? Probably not. Is it necessary to validate the system as if it's a custom-built, homegrown system? Absolutely not. Regulators want life science companies to take a risk-based approach to computer system validation/assurance (CSV/A). At B3 Quality Consulting, LLC, we call that Right-Sized Quality™. What are the Quality practices you see that are not "right-sized" and don't actually improve quality?

I'm excited to welcome Audrey Brennan to B3 as our newest Quality Consultant! With a strong background in GXP auditing and implementing electronic quality management systems, Audrey brings a pragmatic approach to quality for clinical and pre-clinical stage companies. Her expertise in vendor oversight and managing quality issues will help B3 continue delivering Right-Sized Quality™ solutions and ensuring our clients meet their highest standards of quality. "I love working with start-ups because processes are being developed for the first time and we get to be creative and tailor a quality system specific to the risks that client has to deal with." - Audrey Brennan, MS, CQA Welcome to the team, Audrey! Blake Jensen, MBA Founder, Principal Consultant B3 Quality Consulting, LLC

New FDA Guidance on #DataIntegrity in BA/BE studies, echoing and expanding on many points from the 2018 Guidance on data integrity in cGMP activities. https://lnkd.in/g49ZKvPP "There are really great points in here about ensuring data integrity in ANY study, not just BA/BE. And it's clear sponsors (applicants) are on the hook for data integrity at their vendor sites!" - Kyle Davis, Sr. Consultant, B3 Quality Consulting, LLC #gxp #dataintegrity #qualityconsulting #vendorqualification

Blake Jensen, founder of B3 Quality Consulting, LLC, will be discussing risk assessment in the life sciences tomorrow. It's not too late to register! Thanks to Regulatory Affairs Professionals Society (RAPS) and Sware for hosting the fireside chat to help keep the industry aligned and sensible on this important topic.