---
title: "21 CFR Part 11 Checklist and Questionnaire"
description: "Electronic records and signatures come with strict regulatory requirements. But does your system actually meet them? Use this practical checklist to assess your computer system against key 21 CFR Part 11 requirements and quickly identify potential compliance gaps."
url: https://qbdgroup.com/zh-cn/downloads/checklists/21-cfr-part-11-checklist-and-questionnaire
type: "Checklist"
language: zh-cn
published: 2024-10-15
publisher: "QbD Group"
citation: "QbD Group, \"21 CFR Part 11 Checklist and Questionnaire\", https://qbdgroup.com/zh-cn/downloads/checklists/21-cfr-part-11-checklist-and-questionnaire"
---
# 21 CFR Part 11 Checklist and Questionnaire
> Electronic records and signatures come with strict regulatory requirements. But does your system actually meet them? Use this practical checklist to assess your computer system against key 21 CFR Part 11 requirements and quickly identify potential compliance gaps.

## About This Checklist

21 CFR Part 11 sets requirements for electronic records and electronic signatures used in regulated environments. Assessing whether your computer systems meet those requirements is an essential part of maintaining compliance.

This practical checklist and questionnaire helps you evaluate whether your system generates electronic records, uses electronic signatures or audit trails, controls user access, and falls within the scope of 21 CFR Part 11.

From there, the questionnaire guides you through key compliance areas, including **system validation**, **electronic record controls**, **audit trails**, **access management**, **electronic signatures**, **documentation** and **identification controls**.

## Key Takeaways

- **Determine Whether 21 CFR Part 11 Applies.** Start with a quick evaluation of your system's use of electronic records, electronic signatures, audit trails and user access controls.

- **Evaluate Electronic Record Controls.** Check whether your system supports record authenticity, integrity and reliability, is appropriately validated and can identify altered or invalid records.

- **Review Audit Trails and Data Integrity.** Assess whether records can be retrieved, changes are traceable, data cannot be overwritten and modifications or deletions are properly recorded.

- **Check Access and Security Controls.** Evaluate whether access is restricted to authorized users and whether appropriate procedures exist for system operation, maintenance and change control.

- **Assess Electronic Signature Compliance.** Review how electronic signatures are recorded, displayed and linked to individual records, as well as how user identities and signature components are managed.

- **Verify Identification and Password Controls.** Check requirements around unique credentials, periodic password reviews, temporary access, unauthorized access detection and password-generating devices.
---
Source: https://qbdgroup.com/zh-cn/downloads/checklists/21-cfr-part-11-checklist-and-questionnaire — © QbD Group. Quote freely with attribution and a link back.