Achieve an Ongoing State of TMF Inspection Readiness

TMF best practices to help you prepare and maintain TMF inspection readiness.

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.

Modernizing eTMF to Ensure a Constant State of TMF Inspection Readiness

Recent survey findings show a significant increase (68%) in adoption of modern purpose-built eTMF applications versus 17% in 2014. These applications enable organizations to automate processes, manage documents in real-time, and achieve active trial management. This has a significant positive impact on inspection readiness and TMF management overall compared to other methods.

Daiichi Sankyo's Ongoing Inspection Readiness

Using Vault eTMF milestones and expected document lists.

AstraZeneca Gets
TMF Inspection Ready

Preparing for inspection two weeks after implementation of Veeva Vault eTMF.

Risk-Based Approach
to Inspection Readiness

Ferring and Ipsen share best practices for outsourced clinical trials.

Watch 15-minute video for more insights on latest trends and strategies to modernize clinical operations.

Getting Ready for TMF Inspection

Use this series of checklists to help your organization prepare for a successful regulatory inspection.


TMF inspection readiness: How to create and maintain an inspection-ready culture
Regulatory inspection SOP: How to prepare for
an inspection
Regulatory inspection day: How to successfully navigate a regulatory inspection
Regulatory inspection takeaways: Biotech shares lessons learned from a successful inspection

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 guide 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.