Home / 21 CFR Part 11

21 CFR Part 11

FDA 21 CFR Part 11 vs. EU Annex 11

Maria Anastasia Zormpa

FDA 21 CFR Part 11 vs. EU Annex 11: Key Requirements and Differences

21 CFR Part 11

FDA 21 CFR Part 11 Open vs. Closed System

Desiree Tarranco

21 CFR Part 11 Open vs. Closed System: Examples, Controls, and Key Differences

21 CFR Part 11

FDA 21 CFR Part 11 Audit Trail Requirements

Blagica Ingilizovska

FDA 21 CFR Part 11 Audit Trails: Definition, Requirements, and Compliance

21 CFR Part 11

FDA 21 CFR Part 11 Password Requirements

Maria Anastasia Zormpa

FDA 21 CFR Part 11 Password Requirements

21 CFR Part 11

FDA 21 CFR Part 11 Applicability Assessment

Maria Anastasia Zormpa

FDA 21 CFR Part 11 Applicability Assessment: Definition, Steps, and Compliance

21 CFR Part 11

FDA 21 CFR Part 11 Compliance Checklist

Desiree Tarranco

21 CFR Part 11 Compliance Checklist [PDF & XLS Download]

21 CFR Part 11

FDA 21 CFR Part 11 - Electronic Signature - Electronic Records - Requirements

Desiree Tarranco

FDA 21 CFR Part 11: Definition, Compliance Requirements, Benefits, and Software

21 CFR Part 11

21 CFR Part 11 Common Questions and Answers

Bruna De Lucca Caetano

What is FDA 21 CFR Part 11? (32 Questions and Answers)

21 CFR Part 11

Illustration of 21 CFR Part 11 Training Records Migration

Allan Murphy Bruun

21 CFR Part 11 and Training Records (What You Should Know)

21 CFR Part 11

21 CFR part 11 Noncompliance With Exclamation Mark

Allan Murphy Bruun

21 CFR Part 11 Noncompliances (And How to Avoid Them)

21 CFR Part 11

SimplerQMS

Cookie Policy

Privacy Policy

Copyright © 2026 SimplerQMS. All rights reserved.

Modules

Document Control

Training Management

Change Control

Nonconformance Management

CAPA Management

Complaints Management

Audit Management

Risk Management

Equipment Management

Supplier Management

Electronic Batch Records

Product Management

View all modules

Product

Overview (QMS Software)

Implementation

Compliance

Technology

Pricing

Solutions

Medical Device

Pharma & Biotech

Laboratories

CRO & CMO

Company

About Us

Contact Us

Contact Support

Contact Sales

Experience

Careers

Our Customers

Resources

Blog Articles

Quality Digest Newsletter

View all resources