AIX
Generative AI That Automatically
Validates and Corrects
eCTD Navigation Elements
AiX uses generative AI to analyze the structure of leaf files within a submission package, automatically validating and correcting bookmarks, internal and external hyperlinks, and table of contents consistency. Review results through a browser-based dashboard, with Web API integration available for connecting to external systems.
AIX — VALIDATION DETAIL / SUMMARY
Key Features
Automatic validation and correction of internal and external links
Automatic validation and correction of bookmarks
Consistency checks for table of contents structure and page numbers
Automatic detection and removal of blank pages
Support for Web Fast View optimization
Lifecycle support, including pseudo-replace and hash value updates
Browser-based analysis dashboard
Web API integration with external systems
Where AiX Fits In
Regulatory Publishing Teams
Automate the validation and correction of eCTD navigation elements — bookmarks, links, and tables of contents — to significantly reduce manual review workload.
Quality Control Teams
Export analysis results as PDF or JSON reports, making it easy to pinpoint issues at the package or individual file level.
Teams Seeking Higher Precision
Combine AiX with Miyabira Publish, our rule-based validation platform, for a hybrid approach that pairs AI flexibility with consistent, repeatable validation.
AiX handles validation and correction through generative AI. Pair it with Miyabira Publish, which covers publishing and validation across the full eCTD package, to combine AI flexibility with consistent, rule-based review. For end-to-end visibility and progress tracking across your submission process, Miyabira Review is also worth a look. For a broader foundation supporting your entire regulatory operations, explore Miyabira.