Capabilities
Documentation
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
Versioning
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
