// glossary

Under construction

Terms are listed; definitions are being added. Check back as the series continues.

The working vocabulary of The AI Validation Boundary and the Britt Biocomputing frameworks. Each entry maps to the nearest public FDA (including 21 CFR Part 11), EMA, EU GMP or ICH term, with GAMP® references cited by guide and section and Brazilian ANVISA equivalents to follow. Licensed CC BY 4.0. Last updated October 2026.

The unit of validation

#Probabilistic system

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: The Validation Boundary Inside the House

#Validation boundary

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: The Validation Boundary Inside the House

#Context of use (CoU)

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Validated envelope

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Runtime context

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: Context is King

#Model

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Harness

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: Why AI Governance Fails Without a Control Layer

#Harness surfaces

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: Beyond the Weights

#Guardrail layer

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: Beyond the Weights

#Human-in-the-loop (HITL)

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: Balancing the Equation: Why HITL Is a Variable, Not a Constant

#Human-on-the-loop (HOTL)

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

House of AI Trust

#House of AI Trust

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: House of AI Trust (Mar 2026)

#Layer 1 — Trust Infrastructure

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Inheritance gate

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Layer 2 — AI Governance

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#System Information Card

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#AI inventory triage

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Explainability requirements

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Layer 3 — Control Layer

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Layer 4 — Domain and Process Context

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Layer 5 — Business ROI

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Cross-cutting thread

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Security thread

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: Your Frozen Architecture May Have a Back Door

#Supplier qualification thread

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Probabilistic Validation Lifecycle

#Probabilistic Validation Lifecycle (PVL)

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: Probabilistic Validation Lifecycle (Oct 2025)

#Step 1 — Context of Use

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Step 2 — Risk Tiering

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Step 3 — Evaluation Design

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Step 4 — Acceptance Criteria

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Step 5 — HITL/HOTL Controls

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Step 6 — Continuous Monitoring

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Step 7 — Change Control

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Bounded-variance threshold

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Perturbation testing

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Ground-truth set

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Calibration

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Adaptive conformal prediction

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: The Engineering of Uncertainty

Probabilistic Failure Mode Taxonomy

#Probabilistic Failure Mode Taxonomy (PFMT)

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: Probabilistic Failure Mode Taxonomy (May 2026)

#Error type

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Fabrication

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Misinterpretation

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Contextual misapplication

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Confidence miscalibration

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Boundary violation

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Subgroup performance failure

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Origination point

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Training data

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Retrieval / RAG layer

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Model inference

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Human–AI interface

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Agent orchestration

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Supplier

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Cell

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Multi-cell incident / primary cell

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Unclassifiable

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Coding rules

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Intrinsic vs locatable failure

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: You Can't CAPA What You Can't Locate

#Chance vs assignable cause

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: You Can't CAPA What You Can't Locate

#Error nature

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: You Can't CAPA What You Can't Classify

Capture and evidence

#Unified Capture Layer (UCL)

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: The Last Deterministic Thing: The Unified Capture Layer

#Determinism floor

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Tenancy rule

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#The regress

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Replay / reconstructability

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Determinism (definitions A, B, C)

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Check-set manifest

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Did not run

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: When a Check Doesn't Run

#Action class

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Artifact class

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Configuration hash

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Seeded challenge

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Human performance qualification (HPQ)

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Cognitive forcing function

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Boundaries

#Inheritance boundary

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: The Inheritance Boundary Inside the House

#Trust boundary

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: When the Check Runs Somewhere Else

#Data boundary

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: The Data Boundary Inside the House

#Retrieval split

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Failure dynamics

#Drift

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Harness drift

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: Beyond the Weights

#Endpoint drift

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: Beyond the Weights

#Correlated failure

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: Balancing the Equation

#Measurement problem

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Automation-bias decay

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Silent failure

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Bounded reproducibility

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Remediable vs irreducible

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: Adopted from Tancev (2026)

#Capability paradox

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: The Capability Paradox

VALID Trust

#VALID Trust

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: VALID Trust (May 2026)

#Generative AI validation

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: VALID Trust pillar 1

#Agentic AI governance

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: VALID Trust pillar 2

#Probabilistic acceptance

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: VALID Trust pillar 3

#Continuous monitoring

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: VALID Trust pillar 4

#VALID Trust five steps

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Harness Evidence Worksheet

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: Zenodo (Sept 2026)

Other terms

#Pre-authorized change envelope

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Trust as deliverable

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

Introduced in: AI Trust Is Not a Feeling

Contrast terms (from other frameworks)

#Static vs dynamic (GAMP®)

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Deterministic (draft EU GMP Annex 22)

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

#Non-deterministic (2021 usage)

Definition coming soon.

Regulatory crosswalk: coming soon

GAMP® (ISPE): coming soon

ANVISA (Brazil): coming soon

No matching terms.

License: CC BY 4.0. Free to use and adapt with attribution. The license covers Britt Biocomputing text only; GAMP® references cite ISPE guides by section and do not reproduce ISPE definitions.

GAMP® is a registered trademark of the International Society for Pharmaceutical Engineering (ISPE).

Cite as: Britt K. Glossary — The AI Validation Boundary. Britt Biocomputing; 2026. brittbiocomputing.com