Documentation Engine
Your audit package, assembled automatically.
P4SaMD automatically generates DHF records, risk evidence, verification reports, audit trails, and submission-ready documentation, ensuring constant audit readiness from the first commit to the final release.
Documentation that writes itself, from your work.
The Documentation Engine lets your SaMD team focus on what they do best: building great software. By connecting directly to your SDLC tools and pulling live development data in real time, it compiles the Design History File, Technical File, and all required regulatory evidence continuously and automatically, in your own templates, using your terminology, ready for submission at any point in the development cycle.
Standards Addressed
Built to satisfy the standards that matter most to your auditors.
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