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Guarantee audit readiness with automatic generation of a submission-ready Design History File (DHF)

Data Capture

Ketryx generates Part 11-compliant audit trails directly from your team’s favorite developer tools, like Jira and GitHub. Evidence is automatically created while your developers are coding.

  • Connect Ketryx to any supported development tool
  • Ketryx extracts the relevant text and metadata from each item
  • Ketryx automatically creates a Part 11-compliant record and audit trail of all changes for the item


All work history is automatically generated, stored, retrievable, and immutable.

  • Automatically capture each change in any record
  • Automatically capture all changes and easily identify what changed between versions

Compilation & Configuration

Ketryx automatically compiles all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF).

  • Each document is navigable with a table of contents and appropriate headers
  • Formatted as a formal document ready to be submitted to any regulatory body
  • Options to configure documentation for different jurisdictions—configure your documents to meet your needs

The Ketryx Platform

What is Ketryx?

End-to-End Lifecycle Management Using Your Favorite Development Tools


Integrate development tools, cloud infrastructure, and languages into a single traceable software development lifecycle with enterprise monitoring