---
title: Achieving a 21 CFR Part 11 Compliant eTMF
description: A practical approach to achieving a 21 CFR Part 11 Compliant eTMF slide deck download
---

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# Presentation: Achieving a 21 CFR Part 11 Compliant eTMF

## Are you searching for the perfect eTMF solution?

### This presentation reviews the key attributes that eTMF solutions must have in order to satisfy the regulatory requirements.

This session focuses on a **practical approach to selecting a qualified system**, and configuring, validating and managing a compliant eTMF.  Review key attributes that eTMF solutions must have in order to satisfy the regulatory requirements and discuss **risk-based validation approaches** including the validation of off-the-shelf eTMF systems.  Additionally, change management and long-term record retention requirements within systems are examined.  

**Key areas of focus include:**  
•    Performing a qualification audit for system selection  
•    eTMF attributes required for compliance  
•    Definition of an electronic record  
•    Electronic signatures vs. electronic approval  
•    Risk-based validation approaches for eTMF  
•    Electronic records management, retention and retrieval

### Download Presentation

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