---
title: "EudraLex Volume 4 Annex 11 Compliance Checklist"
description: "How confident are you that your computerized systems meet the requirements of EU GMP Annex 11? Use this practical checklist to review the key compliance areas and identify potential gaps."
url: https://qbdgroup.com/zh-cn/downloads/checklists/eudralex-volume-4-annex-11-compliance-checklist
type: "Checklist"
language: zh-cn
published: 2024-09-17
publisher: "QbD Group"
citation: "QbD Group, \"EudraLex Volume 4 Annex 11 Compliance Checklist\", https://qbdgroup.com/zh-cn/downloads/checklists/eudralex-volume-4-annex-11-compliance-checklist"
---
# EudraLex Volume 4 Annex 11 Compliance Checklist
> How confident are you that your computerized systems meet the requirements of EU GMP Annex 11? Use this practical checklist to review the key compliance areas and identify potential gaps.

How confident are you that your computerized systems meet the requirements of EU GMP Annex 11? This practical checklist helps you review the key compliance areas and identify potential gaps. Use it as a quick starting point for your next compliance assessment.

## About This Checklist

Computerized systems used in GMP-regulated environments need to remain **controlled, validated and fit for their intended use** throughout their lifecycle. Meeting Annex 11 requirements therefore involves much more than validation alone.

This practical checklist translates the key compliance areas of EudraLex Volume 4 Annex 11 into **clear questions you can use to assess** your current systems and processes. It covers topics ranging from risk management, personnel and supplier management to validation, data integrity, audit trails, security and change management.

It also addresses **ongoing controls** such as periodic evaluation, incident management, electronic signatures, business continuity and archiving, helping you build a more complete picture of your Annex 11 readiness.

## Key Takeaways

- **Risk management & validation.** Check whether risk management is applied throughout the system lifecycle and whether validation activities, requirements, testing and documentation are appropriately controlled.
- **Suppliers & service providers.** Review whether third parties are properly assessed, responsibilities are documented and supplier quality information is available where required.
- **Data integrity & storage.** Assess controls around data input, accuracy, migration, protection, accessibility, backups and restoration.
- **Audit trails & change control.** Verify that GMP-relevant changes can be traced and reviewed and that system and configuration changes are managed in a controlled way.
- **Security & incident management.** Review access controls, authorization records and procedures for reporting, investigating and addressing system incidents.
- **Electronic signatures, business continuity & archiving.** Check whether electronic records and signatures, critical-system continuity arrangements and long-term data accessibility are appropriately managed.
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Source: https://qbdgroup.com/zh-cn/downloads/checklists/eudralex-volume-4-annex-11-compliance-checklist — © QbD Group. Quote freely with attribution and a link back.