Is Your TMF Inspection Ready?
MHRA reported an 11% increase in critical TMF findings because of incomplete or inaccessible trial master files. How can you get TMF inspection ready and avoid inspection delays? We’ve prepared these resources to share TMF best practices and guidance from industry experts.
Industry Best Practice
Learn how your peers use active TMF management to achieve TMF inspection readiness.
Frequently Asked Questions
Inspection readiness means that your trial master file is adequately prepared for an official review by regulatory authorities. With proper planning and the right technology, your organization can achieve a constant state of inspection readiness. Access this checklist for tips to get started.
A TMF plan is not required, but it is an important way to define the roles and responsibilities of all stakeholders across a study and document content requirements, inspection instructions, and quality check procedures. Read how a biotechnology company aligned business processes, documentation, and tools — and ultimately passed an FDA inspection with only two days’ notice.
It is critical to create and maintain an inspection-ready culture with an active TMF operating model, meaning that study teams manage documents in real-time and apply quality control checks throughout a study. Access the best practice guides on this page for detailed information and checklists your organization can use to create this culture and successfully navigate a regulatory inspection.