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Generative AI for Regulated Teams

Streamline your TPLC with GenAI

 

AI automation with human oversight for fast, audit-ready documentation.

Your teams want to use AI, but you have concerns about safety and accuracy.

AI is important for us to use internally, but it's too risky without a human in the loop.
VP of R&D at medical device company
A Compliant AI Ecosystem

Let AI do the manual work

Automate documentation and traceability

Spend time managing risk and building innovative products, not assembling or summarizing information. Ketryx Intelligence uses generative AI to create summaries of documents like your SRS, SDS, and release notes. With AI keeping your documentation audit-ready, you’re always one step ahead of compliance requirements.

See what human miss

Ketryx Intelligence leverages AI to scan your entire quality ecosystem—QMS, data, and compliance records—to uncover risks and gaps in seconds, not months. With AI-driven insights, you can detect compliance issues, trace dependencies, and surface hidden patterns that might otherwise go unnoticed by humans.

Speed up development without compromising compliance

Move fast without breaking compliance. Ketryx Intelligence suggests improvements, answers regulatory questions, and generates content with redlines and additions highlighted, keeping a human in the loop for oversight. By embedding AI into your workflows, you release faster without sacrificing safety or compliance and simultaneously improve alignment between Quality, Regulatory, and R&D teams.