Design history files were not written with coding agents in mind.

Regulated medical software expects traceability from requirement to implementation to verification. A coding agent inserts an author into that chain that your documentation has no field for. PromptWake records that author, so the trace stays unbroken.

Where it matters first

Anything in the clinical path: dosing logic, device communication, decision support and the code that formats what a clinician reads.
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Traceability that includes the agent

Each line can be tied back to the prompt and model that produced it, which keeps a design history file complete rather than silently partial.

  • Prompt retained in full
  • Model where the tool exposes it
  • Line-level attribution

Review evidence, not review assumption

The record separates what an agent produced from what a person changed afterwards, so 'reviewed by a qualified engineer' can be demonstrated rather than asserted.

Retention that means archiving

Records are kept for the period you set. Retention archives rather than deletes, because a record that disappears on request does not support a claim years later.

The question comes before the incident

Nobody asks how AI-written code entered a repository until something goes wrong or somebody audits it — and by then the record either exists or it does not. PromptWake is cheap to run before you need it and impossible to reconstruct afterwards.

Questions this sector asks

Is PromptWake a validated system?

No, and no tool should tell you otherwise about your own validation. It produces evidence that goes into your process; validating that process remains your responsibility.

Does patient data end up in the record?

Only if it is in your prompts. Capture is local by default, secrets are stripped before writing, and self-hosting keeps everything inside your own environment.

How far back can we go?

To the point the recorder was installed. Earlier code is reported as unknown rather than attributed, which is why starting before you need the evidence matters.

Clinical software is audited on its record, not its intent.

See what a month of AI-assisted development looks like when it is written down as it happens.