ADR 0017: Pilot scope, light validation package and status transitions

Status: Accepted
Date: 2026-09-14
Deciders: Founder

Context

The product carried every product at designed with illustrative data. Phase 2 makes agents do real work with real data for a mid-size biotech between discovery and IND. Buyers ask what the system is validated for; regulators distinguish operational-efficiency uses from evidence-generating ones.

Decision

The pilot is positioned once and everywhere as non-GxP decision support with a light validation package (URS covering approval workflow, SOP binding, audit trail, permissions, signatures, connector reads and backup/restore; risk assessment; requirement-to-test traceability; test evidence; release notes; change control).
Evidence, Plans and Review move designed -> preview when the R1 gates pass and -> available (discovery and preclinical scope) at R2 after the evaluation suite passes; Progress stays preview; clinical and manufacturing objects stay designed or roadmap.
Every agent capability carries a plain-language context of use, limitations and a risk class (operational | evidence_generating) rendered in the product; the claims register holds the same text.
The evaluation suite starts from illustrative public material, labelled as such, and is replaced by design-partner data under agreement.

Consequences

forge.config.json, contract section 1, CLAUDE.md, the docs status page and CLAIMS-REGISTER.md change together on the day of each transition.
No number appears in copy without a register row (streaming ceiling, cold start, extraction quality).

Alternatives considered

Claim GxP readiness: no validation evidence exists; rejected.
Stay at designed throughout the pilot: misrepresents working software; rejected.

Follow-ups

Validation package v1 before R2 go-live; periodic review minutes monthly.