WHITE PAPER
Achieving FDA 21 CFR Part 11 Compliance Bulletin

This comprehensive white paper details how AssurX software is designed to meet FDA 21 CFR Part 11 compliance requirements for electronic records and electronic signatures. Our solution covers key aspects of compliance, ensuring that your organization adheres to industry standards and maintains secure, reliable data management.

Introduction to FDA 21 CFR Part 11 Compliance

FDA 21 CFR Part 11 compliance is crucial for organizations handling electronic records and signatures. AssurX software provides the necessary controls and configurations to meet these regulatory requirements. This white paper explores how our software supports compliance with FDA 21 CFR Part 11, enhancing your organization’s data integrity and security.

Key Sections Covered:

• SUBPART A – GENERAL PROVISIONS
  • 11.1 Scope: Understand the extent of FDA 21 CFR Part 11 compliance requirements.
  • 11.2 Implementation: Learn how to implement compliance measures effectively.
  • 11.3 Definitions: Familiarize yourself with essential compliance terminology.
• SUBPART B – ELECTRONIC RECORDS
  • 11.10 Controls for closed systems: Explore controls for maintaining secure closed systems.
  • 11.30 Controls for open systems: Discover measures for protecting open systems.
  • 11.50 Signature manifestations: Ensure proper electronic signature displays.
  • 11.70 Signature/record linking: Maintain integrity by linking signatures to records.
• SUBPART C – ELECTRONIC SIGNATURES
  • 11.100 General requirements: Comprehend the general requirements for electronic signatures.
  • 11.200 Electronic signature component and controls: Implement effective signature controls.
  • 11.300 Controls for identification codes/passwords: Secure identification codes and passwords.