What you are selling
A mechanical first pass on quality documents so scarce human review time goes to judgment. Dry Run returns per-criterion findings with evidence from the document. It does not approve, clear, or certify anything.
Say this
- Screens SOPs, deviations, CAPAs, protocols, reports against fixed criteria
- Flags mechanical issues (dates, versions, circular root-cause language, ALCOA gaps where visible)
- Returns a work list: FLAG / REVIEW / no issue found — per criterion
- Human owns every edit and every disposition decision
- Documents are not retained by default (stateless product posture)
- Regulatory citations on criteria are human-authored, not invented by the model
Never say this
- “Inspection ready” / “FDA ready” / compliance score
- “AI approved” or “cleared for submission”
- “Validates signatures” or “verifies wet ink”
- “Replaces QA / QP / consultant judgment”
- “Guarantees no 483s”
- Implied certification of the scientific root cause
Sample scope language
“Consultant will run a Dry Run triage pass on up to N client-provided quality documents (document types: …). Output is a per-criterion findings list with document excerpts for human review. Dry Run does not constitute document approval, regulatory clearance, or a substitute for quality unit judgment.”
“We’ll use Dry Run to catch avoidable mechanical issues before the workshop. You still own every disposition. Simulated demo available first if legal wants to see the shape of the output.”
Where it sits in the engagement
- Before the binder walk — triage the stack so the room focuses on hard problems (binder checklist).
- During document scrub — consultant or client SME works FLAG/REVIEW items; Dry Run does not close CAPAs.
- Handoff — export CSV/JSON/PDF into the client’s tracking sheet (export map).
Liability posture. If a client asks for a “green light,” decline. The tool’s summary is counts only — a work list, never a grade.