PHA documentation automation
AI-assisted drafting of structured process hazard analysis outputs from design and clinical source documents—with expert review at every step.
60%
Faster submission preparation
Challenge
Risk assessments required repetitive extraction and structuring of information across design documents, clinical data, and prior submissions—bottlenecking regulatory throughput.
What we did
We built a human-in-the-loop workflow that reads source documents, proposes risk statements, and populates PHA templates for regulatory team sign-off.
Results
Regulatory teams maintained ownership of all decisions while offloading repetitive document assembly. Submission timelines compressed without compromising audit readiness.
Discuss a similar engagement
We typically start with a scoped proof of concept before production deployment.