WHITE PAPER

FDA 21 CFR Part 11 Compliance Bulletin

This AssurX FDA 21CFR Part 11 Compliance Bulletin white paper describes the designed, intended compliance of the AssurX software with FDA 21CFR Part 11 Electronic Records: Electronic Signatures guidance from a software functionality and configuration aspect.

This paper covers:

  • SUBPART A – GENERAL PROVISIONS
    • 11.1 Scope
    • 11.2 Implementation
    • 11.3 Definitions
  • SUBPART B – ELECTRONIC RECORDS
    • 11.10 Controls for closed systems
    • 11.30 Controls for open systems
    • 11.50 Signature manifestations
    • 11.70 Signature/record linking
  • SUBPART C – ELECTRONIC SIGNATURES
    • 11.100 General requireiments
    • 11.200 Electronic signature component and controls
    • 11.300 Controls for identification codes/passwords

AssurX Cloud QMS Product Brochure

The AssurX Cloud QMS system (cloud-based quality management system) delivers the same features and functionality as AssurX’s comprehensive quality, risk, and regulatory compliance management solutions quickly. The AssurX Cloud provides the development, delivery, maintenance, and ongoing upgrades of the core software to focus on your enterprise’s core competencies.

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