Support change-control evidence for medical device software

The problem

Software regulated as a medical device needs traceable, reproducible change control feeding the design history file, per the design-control expectations of 21 CFR 820.30. When an AI assistant contributes to a change, teams struggle to show the change was controlled and documented to the standard the FDA expects.

How Encephalon addresses it

Enterprise Intelligence captures the AI’s role in each change as a structured record, holds AI-assisted work to your documented change-control procedure, and retains the rationale behind decisions where reviewers can find it. This supports your change-control evidence for the design history file. Two boundaries we state plainly: it is not a substitute for a validated 21 CFR Part 11 records system, and we do not claim it conforms to that standard. It makes your existing quality posture more defensible. It does not make you compliant.

The outcome

Change evidence that feeds the design history file with less manual reconstruction, and less validation rework when AI is part of the development workflow. Your quality team spends its time reviewing changes instead of reassembling their history.

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The Practice is a full-service implementation, not a self-serve subscription. We require an executive sponsor for every engagement because AI adoption is organizational change, not a technology deployment.