ILLUSTRATIVE DEMONSTRATION — NOT VALIDATED, NOT FOR GXP USE.
All data synthetic; any company shown is fictional; no real person is named. Every result on this page was
precomputed by the tiering engine (); nothing is computed in your browser.
A concept demonstration of the AI Governance Board Builder — not a product release.
Stand up your site's AI governance board — and see the software do the work
This concept demo walks the full lifecycle of a pharma AI governance board — charter, discovery,
risk-tiering, validation posture, operation, and review — and adjusts to the site profile you choose below.
The idea it demonstrates: the software guides your own team through designing, structuring, implementing, and
running the board — self-serve today for the tested site class, and honestly routed to a firm-led engagement
for every other profile — rather than a consulting engagement doing all of it for you. A named human holds
every approval seat; no AI approves anything, here or in the real thing.
Your context
Describe a site like yours
Everything below re-computes from this profile. (Demo profiles only — no information is stored or sent anywhere.)
A1
Charter & constitute — the board is designed around named humans
The software drafts the charter, seat map, and RACI for your profile. Two invariants are not
configurable, because the regulations are not:
The seat map the software proposes
Every seat is a role until your organization names a real person to it. The software never
invents a name and never puts an AI agent in an approval seat.
RACI (excerpt)
A2
Discover & inventory — find the AI you already have
A fictional site's discovery result, tiered for your profile. In a real engagement your own
inventory is captured with a structured intake and a qualified human confirms every factor.
A3
Risk-tier & design controls — try it on one of your own AI uses
Describe an AI use the way the intake does. The tier, routing, and floors shown are the engine's
precomputed output for exactly this combination — the same deterministic logic for every visitor.
A4
Validate & qualify — controls scale with the tier
Record-level controls the software assigns per tier (shown verbatim, with provenance):
Honesty note: this demo itself is not validated and is not for GxP
use. In the real product, validation and Part 11 qualification are engagement-level work performed under
your quality system — the demo only illustrates how the software scopes it.
A5
Operate — the board runs a lifecycle, not a meeting
Rollout waves the software sequences
A6
Review & improve — the gate that keeps it honest
Effectiveness reviews, KPI trends, and incident→CAPA loops close the lifecycle. The board
re-checks its own configuration gate whenever your profile changes — the same rule you saw at the top of this
page. The diagnostic's dated open-items list — a work list your team can execute yourselves — is where
improvement starts.
What a year of the board looks like (synthetic sample)
19 AI-use events assessed this year — new intakes, vendor AI-feature
releases into already-validated systems, and regulatory changes.
4 assessments triggered by a vendor's release schedule, not
yours — a change to your validated system that arrived on their calendar.
2 uses changed tier on annual review — one up (new data source), one
retired.
1 incident → CAPA loop closed: a suspended use, a §211.192-path
investigation, and a preventive control the next intake inherits.
Your output
The board starter pack your selections produce (demo — synthetic data)
This panel regenerates from every selection you make above. In the real product this lands in
your eQMS as a controlled draft your named humans review and sign — here it is an illustration you can print.
The printout carries the same demo labeling.
What this demo does NOT do
It is not validated, and nothing here may support a real GxP decision.
It stores and sends nothing — your selections exist only on this page.
It never names a person: every accountability seat is a role filled by a real human at deployment.
It does not replace your quality system, and its outputs are illustrations, not records.