Only for regulated (GxP) use?

No. For R&D, we right‑size controls—but we design measurements now so you can scale later without rework.

We already have data scientists—why you?

I provide the credibility plan, eval design, and lifecycle controls so leadership can green‑light and QA can defend it.

Vendors say they’re “validated.”

Good—that’s a start. You still own context‑of‑use evidence in your environment. I integrate supplier artifacts into your audit pack.

Who owns validation internally?

QA/CSV + the Business Process Owner. I work in your tenant, align to your QMS, and provide the plan/report and artifacts. Regulatory/Medical advise on claims; IT/Sec covers tenancy and access.

What quality metrics will we get?

Every engagement reports IRA vs. golden set, safety hard-fail rate (e.g., invented citations, prescriptive advice), and rework % (pre/post calibration)—plus drift/monitoring KQIs after go-live.

What’s in the Evidence Pack, exactly?

Intended use & URS • risk register with acceptance criteria • sampling plan & golden set • IRA targets & calibration logs • executed IOQ/PQ with deviations/CAPA • URS↔tests trace matrix • change control (versioned prompts + release notes & rollback) • monitoring log with drift triggers and re-validation outcomes.

Can’t we just pair an ML engineer with a validation engineer?

You’ll get a demo; you may not get an audit-ready evaluation system (risk-tied criteria, calibrated golden set with IRA targets, versioned prompts/RAG, release notes & rollback, and a periodic review plan). That integrated system is what I deliver.

Do you qualify our tools?

Yes. I offer Tool Qualification (TQ-Lite): risk-based Part 11/CSA checks (audit trail/e-sig, traceability, roles/segregation, backup/restore, integration identity) executed in your tenant.

Data & privacy—do you need PHI?

Prefer synthetic/de-identified data. No PHI unless explicitly scoped via DPA. Clinical-adjacent work is non-diagnostic by default unless we agree otherwise.

Do i need to wait until Q1 2026?

No! Discovery and pilots can start now.