Montrium

“Quality event” is a pretty broad term. So, what do we actually mean when we’re talking about quality events? We’ve put them into 6 different categories: 📁 Process deviations 📁 Audit observations 📁 Inspection findings 📁 Departure from regulations (GCP, GLP & GMP) 📁 Out of specifications 📁 Non-conformances Check out what each one entails below.

To all the biopharmas getting started on your quality journey, you’ll want to read this. Do you ever find yourself wondering: “How am I going to develop the key processes that will give structure to my organization?” If you said “yes,” the best place to begin is with process lists. We’re sharing our cheat sheet on process lists to help you get started.

Has the CDISC TMF Reference Model made TMF management more complicated? In episode 2 of the State of TMF podcast, Karen Roy responds to some of your feedback about the TMF RM. What are your thoughts on the CDISC TMF Reference Model? Let us know in the comments!

This one goes out to all the young biopharmas just getting started with their quality processes. 🤝 It’s not easy out there in the world of managing quality events. But luckily, we’ve been able to learn from experience and can share some advice. Here are some of our cheat codes to ensure a robust quality event CAPA process. 👇

We’ve got exciting news to share! 🎉 Our President and CEO, Paul (Fenton) Carter is officially the Incoming Co-chair of the CDISC TMF Reference Model Steering Committee! Alongside Incoming Co-Chair, Jamie Marie T., Paul will be leading the development of eTMF exchange standards and helping advance the recently-launched TMF Reference Model V4 initiative that is poised to bring the TMF community into a new chapter embracing data-driven environments. We’d also like to extend our kudos to former Chair, Karen Roy who has led the TMF Reference Model project for the last 15 years. Thank you for your dedication to advancing the project and promoting knowledge-sharing and community in the TMF world.  Big things are on the way, TMF’ers! We can’t wait to see what the future holds. 

✨ Quality is an art form ✨ ...and so are quality problems. Recognize one of your own reactions? Let us know below!

What’s the difference between the TMF and the ISF, anyway? Let’s settle this—for good. The Investigator Site File (ISF)—sometimes referred to as the regulatory binder—is a collection of all study-related documents collected at the site. The ISF is considered sometimes to be the “site TMF.” Plus, the ISF (or site TMF) is actually a critical part of the overall TMF, not just a bunch of documents that sites have to maintain. At least that’s how regulators view it! Both the ISF and sponsor TMF make up the TMF we have all come to know, and to some degree, love. To help make it a bit clearer, we made this handy visual below for you to understand the overlap between the ISF and TMF.

That notice of upcoming inspection can be a scary sight. But it doesn’t necessarily have to be. The solution all comes down to one word: Prepare. As the TMF is the backbone of your clinical trial documentation, an ongoing review of its content by different stakeholders is going to make or break inspection success. Rather than pushing TMF inspection readiness aside and waiting for the notice of inspection to come in to start reacting, aim to operate a continuous level of inspection readiness. Let’s be proactive rather than reactive. What’s your best inspection readiness tip?

We’re all about constant improvement here at Montrium. And we think the only way for the life sciences industry to constantly improve is if we all take the time to learn from one another. What do you think we should take away from the top 5 most common MHRA TMF inspection findings? 💭

Improving collaboration between sites, sponsors, and CROs starts with one three-letter word: Why. When coordinating with sites, it’s crucial for sponsors and CROs to explain why documentation needs to be timely, complete, and accurate. It’s the best way to help the site help YOU. Matt shares his view from the site perspective: