---
title: FDA 21 CFR Part 11 checklist
canonical: "https://www.qualio.com/resources/fda-cfr-part-11-checklist"
updatedDate: "2026-10-26T16:24:04.000Z"
description: "Download Qualio's FDA 21 CFR Part 11 checklist. A step-by-step checklist to help life sciences teams stay compliant and audit-ready."
---

## FDA 21 CFR Part 11 checklist PDF

Meet every requirement of FDA 21 CFR Part 11.

## Download your FDA 21 CFR Part 11 checklist PDF to:

### Get to grips with the FDA's requirements for the integrity, quality and compliance of electronic records and signatures

### Understand the steps your business needs to take, from validation and audit trailing to record copying and retention

### Access an ordered step-by-step checklist and drive an organized, controlled pathway to compliance

## What you'll get

### Compliance checklist

Detailed step-by-step breakdown of the key requirements of FDA 21 CFR Part 11

### Section-by-section blueprint

Work through a sectioned series of actions and requirements to embed compliance

### Peace of mind

Tick off each requirement as you fulfil it and work towards airtight electronic record and signature compliance