AI GOVERNANCE & COMPLIANCE INFRASTRUCTURE
The regulators gave you the map.
ComplianceIQ is the GPS
Most AI governance programs describe what good looks like. ComplianceIQ operationalizes
how — turn-by-turn, from assessment through remediation to inspection-ready artifacts — so quality,
regulatory, and digital teams share one compliance language end to end.
The backbone: FIVES scoring across five rule layers, Execution Integrity for deterministic and auditable workflows,
Trust Velocity for the speed at which you can ship compliant AI without losing regulatory confidence, and a Trust
score leadership can track — one signal from concept to audit-ready production.
PromoCX and other TFives suite products build on the same ComplianceIQ infrastructure: shared regulatory lineage,
explainable findings, and audit trails — not a patchwork rebuilt at every product boundary.
Most AI governance programs describe what good looks like. ComplianceIQ
operationalizes how — turn-by-turn, from assessment through remediation to
inspection-ready artifacts — so quality, regulatory, and digital teams share one
compliance language end to end.
The backbone: FIVES scoring across five rule layers, Execution Integrity for deterministic
and auditable workflows, Trust Velocity for the speed at which you can ship compliant AI
without losing regulatory confidence, and a Trust score leadership can track — one signal
from concept to audit-ready production.
PromoCX and other TFives suite products build on the same ComplianceIQ infrastructure:
shared regulatory lineage, explainable findings, and audit trails — not a patchwork rebuilt
at every product boundary.
The Problem Worth Solving
The Problem Worth Solving
Compliance stalls AI in production
Manual programs take months; many initiatives never reach production-ready deployment because
governance, evidence, and regulatory mapping stay disconnected from how models are built and operated.
Guidance is not an operating system
High-level principles describe outcomes — not executable workflows, proportionate validation criteria,
or a single thread from assessment to remediation to inspection-ready artifacts.
Tools don't share one language
Quality, regulatory, medical, and digital teams juggle siloed reviews. What should be defensible
under agency pressure is often reassembled under deadline — not built as you work.
Compliance stalls AI in production
Manual programs take months; many initiatives never reach production-ready
deployment because governance, evidence, and regulatory mapping stay disconnected
from how models are built and operated.
Guidance is not an operating system
High-level principles describe outcomes — not executable workflows, proportionate
validation criteria, or a single thread from assessment to remediation to inspection-ready
artifacts.
Tools don't share one language
Quality, regulatory, medical, and digital teams juggle siloed reviews. What should be
defensible under agency pressure is often reassembled under deadline — not built
as you work.
Compliance stalls AI in production
Manual programs take months; many initiatives never reach production-ready deployment because
governance, evidence, and regulatory mapping stay disconnected from how models are built and operated.
Guidance is not an operating system
High-level principles describe outcomes — not executable workflows, proportionate validation criteria,
or a single thread from assessment to remediation to inspection-ready artifacts.
Tools don't share one language
Quality, regulatory, medical, and digital teams juggle siloed reviews. What should be defensible
under agency pressure is often reassembled under deadline — not built as you work.
One architecture — TFives rule model
One architecture —
FIVES five-layer rule model
Every assessment, remediation, and audit output draws from the same rule hierarchy. No layer bypasses the one above it.
Every assessment, remediation, and audit output draws from the same rule hierarchy.
No layer bypasses the one above it.
Convergence Layer
Dual Compliance Convergence — Traditional + AI
Traditional compliance (GxP, promotional, safety) and AI/ML governance (bias, explainability, drift, ethics) converge on one rules engine
and one audit trail. The same run checks both dimensions — no separate stack for AI, no afterthought governance bolted on after the fact.
Traditional compliance (GxP, promotional, safety) and AI/ML
governance (bias, explainability, drift, ethics) converge on one
rules engine and one audit trail. The same run checks both
dimensions — no separate stack for AI, no afterthought governance
bolted on after the fact.
Traditional compliance (GxP, promotional, safety) and AI/ML governance (bias, explainability, drift, ethics) converge on
one rules engine and one audit trail. The same run checks both dimensions — no separate stack for AI, no afterthought
governance bolted on after the fact.
AI + ML + Generative AI stack
AI governance built in, not bolted on
Model registry, prompt versioning, bias and drift controls, and
human oversight routing — governed by the same L1–L5
hierarchy as traditional compliance workflows.
Model registry, prompt versioning, bias and drift
controls, and human oversight routing — governed
by the same L1–L5 hierarchy as traditional
compliance workflows.
Traditional compliance stack
GxP, promotional, and safety in one pass
GxP quality controls, promotional compliance, and
pharmacovigilance obligations run on the same engine — one
check, not three programs reconciled after the fact.
GxP quality controls, promotional compliance, and
pharmacovigilance obligations run on the same
engine — one check, not three programs reconciled
after the fact.
How ComplianceIQ works
Capability at each step · Content adapts to role, therapeutic area, AI modality, and deployment
Capability at each step · Content adapts to role, therapeutic area, AI modality,
and deployment
SCOPE THE PROGRAM
Context that matches reality
Set therapeutic area, model type, deployment, and persona so assessments surface what applies — not generic one-size-fits-all checklists.
Stage gates align depth of review to program maturity.
Scopes the right L1–L5 rule layers for your program before a single question is answered.
Set therapeutic area, model type, deployment, and persona so
assessments surface what applies — not generic one-size-fits-all
checklists.
Stage gates align depth of review to program maturity.
Scopes the right L1–L5 rule layers for your program before a
single question is answered.
Set therapeutic area, model type, deployment, and persona so assessments surface what applies — not
generic one-size-fits-all checklists. Stage gates align depth of review to program maturity.
Scopes the right L1–L5 rule layers for your program before a single question is answered.
DIGITAL & AI LEADERSHIP
ASSESS DEEPLY
Structured coverage at enterprise scale
Question libraries spanning all five rule layers with additional depth where your use case requires — specialized modalities, therapeutic
context, persona-level obligations. Progress, scoring, and versioning support repeat runs as designs evolve.
Feeds the Trust score with traceable, versioned evidence — not a point-in-time snapshot.
Question libraries spanning all five rule layers with additional depth
where your use case requires — specialized modalities, therapeutic
context, persona-level obligations. Progress, scoring, and versioning
support repeat runs as designs evolve.
Feeds the Trust score with traceable, versioned evidence — not a
point-in-time snapshot.
Question libraries spanning all five rule layers with additional depth where your use case requires — specialized
modalities, therapeutic context, persona-level obligations. Progress, scoring, and versioning support repeat runs
as designs evolve.
Feeds the Trust score with traceable, versioned evidence — not a point-in-time snapshot.
REGULATORY & QUALITY
CLOSE GAPS
From findings to roadmap
Trust score, prioritized gaps, and remediation paths — board-ready FIVES reporting and a remediation centre so fixes are owned and
tracked, not lost in email.
Execution Integrity: every remediation step is repeatable, traceable, and reviewable — manual variance eliminated.
Trust score, prioritized gaps, and remediation paths — board-ready
FIVES reporting and a remediation centre so fixes are owned and
tracked, not lost in email.
Execution Integrity: every remediation step is repeatable, traceable,
and reviewable — manual variance eliminated.
Trust score, prioritized gaps, and remediation paths — board-ready FIVES reporting and a remediation centre
so fixes are owned and tracked, not lost in email.
Execution Integrity: every remediation step is repeatable, traceable, and reviewable — manual variance
eliminated.
QUALITY & COMPLIANCE
EVIDENCE & ANSWERS
Evidence Vault & regulatory Q&A
Retain and tie evidence to decisions. Ask Rexi, the regulatory Q&A engine, answers questions from authoritative guidance and quality
expectations — so "why" holds up when Legal or QA asks.
Trust Velocity: evidence ready before the question arrives — the speed to compliant production without losing regulatory confidence.
Retain and tie evidence to decisions. Ask Rexi, the regulatory Q&A
engine, answers questions from authoritative guidance and quality
expectations — so "why" holds up when Legal or QA asks.
Trust Velocity: evidence ready before the question arrives — the
speed to compliant production without losing regulatory confidence.
Retain and tie evidence to decisions. Ask Rexi, the regulatory Q&A engine, answers questions from authoritative
guidance and quality expectations — so "why" holds up when Legal or QA asks.
Trust Velocity: evidence ready before the question arrives — the speed to compliant production without losing
regulatory confidence.
LEGAL & REGULATORY
GOVERN & OVERSEE
Compliance, governance, and responsible AI
Unified entry points for regulatory intelligence, policy and SOP alignment, human review where required, model lifecycle and drift, ethics
and responsible-AI controls — oversight that matches both enterprise policy and external obligations.
Both AI governance and traditional compliance obligations checked in one pass — the Convergence Layer in operation.
Unified entry points for regulatory intelligence, policy and SOP
alignment, human review where required, model lifecycle and drift,
ethics and responsible-AI controls — oversight that matches both
enterprise policy and external obligations.
Both AI governance and traditional compliance obligations checked
in one pass — the Convergence Layer in operation.
Unified entry points for regulatory intelligence, policy and SOP alignment, human review where required,
model lifecycle and drift, ethics and responsible-AI controls — oversight that matches both enterprise policy
and external obligations.
Both AI governance and traditional compliance obligations checked in one pass — the Convergence Layer in
operation.
ENTERPRISE PROGRAMS
SEE WHAT APPLIES
Rules Intelligence — one library, whole lifecycle
When a team needs to show why a control applies — from development through post-market vigilance — Rules Intelligence surfaces
the relevant obligations from the L1–L5 hierarchy in one place instead of reconciling separate rulebooks by hand.
The same rule that governs a development-stage AI check governs the post-market vigilance obligation — one corpus, consistent lineage.
Exact modules and rule coverage depend on your program configuration. Scope confirmed under agreement.
When a team needs to show why a control applies — from
development through post-market vigilance — Rules Intelligence
surfaces the relevant obligations from the L1–L5 hierarchy in one
place instead of reconciling separate rulebooks by hand.
The same rule that governs a development-stage AI check governs
the post-market vigilance obligation — one corpus, consistent lineage.
Exact modules and rule coverage depend on your program
configuration. Scope confirmed under agreement.
When a team needs to show why a control applies — from development through post-market vigilance —
Rules Intelligence surfaces the relevant obligations from the L1–L5 hierarchy in one place instead of reconciling
separate rulebooks by hand.
The same rule that governs a development-stage AI check governs the post-market vigilance obligation — one
corpus, consistent lineage.
Exact modules and rule coverage depend on your program configuration. Scope confirmed under agreement.
REGULATORY & QUALITY
Outcomes — Who It Benefits
REGULATORY & QUALITY
Inspection-ready narrative
Faster confidence in what ships
Traceable assessments, remediation, and
evidence — aligned to evolving FDA and
EU expectations for AI in life sciences,
including vigilance-relevant workflows
where GVP applies
Traceable assessments, remediation, and evidence — aligned to
evolving FDA and EU expectations for AI in life sciences, including
vigilance-relevant workflows where GVP applies
Traceable assessments, remediation, and evidence — aligned to evolving FDA
and EU expectations for AI in life sciences, including vigilance-relevant
workflows where GVP applies
DIGITAL & AI LEADERSHIP
Higher Trust Velocity
Defensible evidence, not reconstructed files
Faster path to compliant production with
a clear Trust score and gap story for the
board — platform economics versus
open-ended consulting cycles
Faster path to compliant production with a clear Trust score and gap
story for the board — platform economics versus open-ended
consulting cycles
Faster path to compliant production with a clear Trust score and gap story
for the board — platform economics versus open-ended consulting cycles
ENTERPRISE PROGRAMS
One backbone, many
products
Less firefighting when agencies ask
Same infrastructure powers ComplianceIQ
and specialized suites — consistent rules
semantics, scoring, and audit language
across solutions
Same infrastructure powers ComplianceIQ and specialized suites —
consistent rules semantics, scoring, and audit language across solutions
Same infrastructure powers ComplianceIQ and specialized suites — consistent
rules semantics, scoring, and audit language across solutions
What Leaders Recognize
“We don't need another slide deck — we need the
same compliance language from assessment
through remediation and what we show the
agency.”
VP, Quality & Compliance — global pharma
“If it can't show the rule, the gap, and the evidence,
it doesn't help when the board or FDA asks.”
Head of Regulatory Operations — life sciences
“We're standardizing on one governance spine so
AI products don't each invent their own compliance
stack.”
Chief Digital & AI Officer — biopharma
Compliance is infrastructure. Automation without explainable regulatory context is hard to defend — and hard to operationalize across teams.
Compliance is infrastructure.
Automation without citeable rules and lineage is not
defensible in audit — or when the agency asks for the thread.
22 capability divisions. One compliance backbone.
Compliance is infrastructure. Automation without explainable regulatory context is hard
to defend — and hard to operationalize across teams.
Eight capability areas. One compliance backbone.
Eight capability areas.
One compliance backbone.
Representative areas; scope and roadmap confirmed under agreement.
Program Scoping
Persona, therapeutic, modality, and deployment
configuration — stage gates align depth to maturity
Structured Assessments
Enterprise-scale libraries across all five FIVES layers,
with versioning and progress tracking feeding the
Trust score
Remediation & FIVES
Prioritized gaps, roadmaps, and board-ready FIVES
outputs — Execution Integrity for closure, not one-off
tickets
Evidence Vault
Evidence tied to decisions; Ask Rexi for answers
grounded in the sources your teams must cite
Rules Intelligence
Submissions & Labeling
Support
L1–L5 rule hierarchy surfaced in one place across the
lifecycle — development through post-market vigilance
Governance & Policy
Regulatory Submission
Tracking
Policy and SOP alignment, human review, model
lifecycle, drift, compliance matrix — oversight without
orphan processes
Responsible AI & Ethics
Dimensions, review gates, attestation — Trust Velocity
and trust together, not one at the expense of the other
Suite Solutions
PromoCX and other TFives products run on
ComplianceIQ infrastructure — shared rules, scoring,
and audit language across the suite
For pharma, biotech, and GxP contexts where AI touches regulated workflows. Pricing and packaging confirmed in conversation.
For pharma, biotech, and GxP contexts where AI touches regulated workflows.
Pricing and packaging confirmed in conversation.
Map ComplianceIQ to your Roadmap
See The Thread On
Your Roadmap
We'll connect the GPS narrative to your functions — where Trust score and Trust Velocity matter for your stage gates — and how suite products share the same rules corpus
and Execution Integrity. Bring your current process; we'll map it to capabilities, not a generic deck.
We'll connect the GPS narrative to your functions — where Trust score
and Trust Velocity matter for your stage gates — and how suite products
share the same rules corpus and Execution Integrity. Bring your current process;
we'll map it to capabilities, not a generic deck.
We'll connect the GPS narrative to your functions — where Trust score and Trust Velocity matter for your stage
gates — and how suite products share the same rules corpus and Execution Integrity. Bring your current process;
we'll map it to capabilities, not a generic deck.