Resource Center

This TMF Toolkit is a curated collection of useful links, tools and resources compiled by TMF subject matter experts to support the TMF community. Whether you're new to the TMF space or a long-time pro, this living document is designed to grow with you. Bookmark it and check back often for new content and updates.

In collaboration with Adobe, we’ve published a detailed white paper exploring how Acrobat Sign Solutions supports compliance with 21 CFR Part 11 and EU Annex 11, and what your organization must do to stay audit-ready. 

Read the report everyone's talking about! With insights from over 500 TMF professionals, you won't want to miss this.

In this first-of-its-kind white paper, Montrium's experts detail their new methodology for risk-based TMF management. It goes beyond simply explaining the theory behind risk-based approaches to providing worked examples that illustrate how you can implement this model within your own organization.

The State of TMF Industry Report 2023 is the largest report of its kind, featuring proprietary data collected from 245 TMF professionals and analyses from Montrium's seasoned experts.

Our free guide breaks down the advantages and disadvantages of owning a sponsor eTMF system vs a CRO-owned eTMF system.

Our free RFI template helps get all of the critical criteria you need to evaluate eTMF software vendors.

Discover what it takes to get from A-to-Z and manage your TMF internally with our free guide.

This guide will help select the right eTMF solution for your team with expert guidance and advice.

Our TMF checklist will provide you with a clear action plan as you prepare for your inspection.

The report includes the results of our COVID-19 and TMF Management Survey, with views representing a wide range of industry stakeholders, including pharmaceutical and biotech sponsors, and CROs.

This buyer’s guide is designed to help you step-by-step towards selecting the right regulatory EDMS solution and vendor.

Not sure where to start when it comes to selecting the right software for your business? Check out this free checklist.

Build a powerful business case internally for implementing an eTMF at your organization with our FREE template!

Our customizable Paper-Based System Cost Calculator lets you input a few basic metrics, and in minutes can tell you the total annual cost of your paper-based system.

The SOP checklist includes a full list of procedural documents needed, information on their function and purpose, and how to get them in place.

This checklist has been designed as a self-guided preparation workbook to help your company plan a successful eTMF implementation.

In this guide, we show you how to approach compliance around computerized systems using both directives, as well as how using GAMP 5 can level the playing field.