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We need to comply with 21 CFR Part 11.

In order to get the benefits of using an electronic system to manage your DMR and DHF, you must comply with the 21 CFR Part 11 regulatory requirement.

With Arena, you can:
  • Comply with FDA regulations.
  • Easily find documentation.
  • Confidently face an audit.

Achieve compliance with Arena.

Arena’s validated solution helps streamline quality and compliance document management. Fully compliant with both CFR 21 Part 11 and Part 820, you get all the benefits of electronic document control while confidently maintaining regulatory compliance.

Built-in system validation (per FDA CFR 820) prior to every release that ensures that the software and systems used for product development operate in a persistently validated state.

Arena lets you achieve—and maintain—compliance.

The auditor was impressed with traceability within Arena. With the click of a mouse, the complete revision history of an item can be displayed, including which ECO made the revision effective and who signed off.

Meredith Yost
Document Services Manager
Align Technology
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Moving From Paper to Electronic Change Management Whitepaper

Learn guidelines for meeting FDA regulations when moving from a paper based system to an electronic system.