Duplicated interpretation
The same underlying obligation is interpreted repeatedly across FDA, EU GMP, ICH, PIC/S and internal standards.
Aurexios
Compliance intelligence for pharmaceutical organizations
Compliance intelligence layer
Connect the regulatory obligations your existing systems keep apart.
Aurexios sits above QMS, document, training, validation, risk and audit systems. It turns fragmented regulatory and operational data into a connected compliance state that can be measured, explained and simulated.
Compliance posture
Connected
87%
Regulatory coverage
24Impacted controls
6Open findings
3Priority signals
Coverage
Impact
Risk
Evidence
The compliance problem
Regulations overlap.
Regulations overlap.
Your systems usually don’t.
Mature pharma platforms execute workflows well. What they rarely provide is a unified intelligence model connecting regulatory obligations, controls, evidence, findings, risk, decisions and change impact across systems.
Weak traceability
Controls, evidence, findings, risks and decisions live in different tools, making the compliance picture difficult to defend.
Manual impact analysis
Regulatory change still requires manual reasoning to determine which controls, procedures and evidence are actually affected.
Fragmented executive view
Activity metrics do not provide a consolidated view of coverage, residual risk, open obligations and data quality.
The Aurexios layer
From regulatory text to defensible compliance intelligence.
Aurexios builds and projects a control-centric regulatory model while your operational platforms remain the systems of record.
Regulatory intelligence
Ingest versioned regulations, normalize clauses, preserve applicability and maintain source traceability for downstream reasoning.
Regulations → clausesCanonical control identity
Generate regulation-agnostic candidates, normalize a stable key and preserve source-specific lineage through ControlVersions and clause mappings.
Many sources → stable identityCoverage intelligence
Project requirement-to-control coverage, calculate explainable percentages and surface uncovered requirements and orphan controls.
Coverage → gapsRegulatory change impact
Use clause diffs and control mappings to identify impacted controls and SOP versions and propagate reassessment needs.
Change → impactAssessment, findings & evidence
Analyze SOP compliance, create traceable findings and connect evidence without replacing the source document system.
Assessment → proofCross-domain AI intelligence
Turn signals from findings, CAPAs, risks and coverage into AI-assisted insights, recommendations and briefings with explicit provenance.
Signals → recommendationsCompliance Digital Twin
Freeze a compliance baseline, apply hypothetical mutations and deterministically simulate propagated impact before operational records change.
What-if → simulationGovernance & audit
Record decision attestations, reviewer accountability, MFA evidence and external approval references with tamper-evident audit chains.
Decision → evidenceReporting & integration
Generate deterministic KPI dashboards and exchange normalized events through secure inbound APIs and HMAC-signed webhooks.
State → visibility
Canonical control intelligence
Different regulations.
Different regulations.
One defensible control truth.
Aurexios is designed to determine when requirements from different regulatory sources express the same underlying obligation—without losing the source-specific wording, applicability or provenance behind that conclusion.
FDARegulatory clause
EU GMPRegulatory clause
PIC/SRegulatory clause
ICHRequirement
Requirement extraction
Normalize the obligation before comparing it.
Canonicalization engine
Reasoned convergence, not simple keyword mapping
01Canonical-key exact lookup
Reuse an existing canonical control immediately when the normalized identity already exists.
02Taxonomy classification
Classify the candidate by control domain, objective and obligation type to constrain the comparison space.
03Candidate retrieval
Retrieve the most plausible existing canonical controls within the relevant taxonomy neighborhood.
04Semantic similarity
Measure conceptual similarity between the new obligation and retrieved canonical-control candidates.
05Structured obligation comparison
Compare subject, required action, object, conditions, applicability and expected evidence—not just wording.
06Equivalence decision
Determine whether the requirement is equivalent to an existing canonical obligation or represents a genuinely new control.
Equivalent
Reuse existing canonical Control
Attach the new source-specific interpretation to the stable control identity.
or
Not equivalent
Create new canonical Control
Establish a new stable identity when the obligation is materially distinct.
FDAControlVersion
EU GMPControlVersion
PIC/SControlVersion
ICHControlVersion
Canonical Control
One stable identity for the underlying compliance obligation
Taxonomy
Normalized intent
Applicability
Control objective
Source-specific truthEvery regulation keeps its own ControlVersion, wording and provenance.
→
Cross-regulation intelligenceThe canonical Control becomes the anchor for coverage, gap, change-impact, evidence and enterprise reasoning.
What changes for your team
Less regulatory duplication.
Less regulatory duplication.
More confidence in the compliance state.
Measured coverage
See covered and uncovered regulatory requirements through explainable, event-driven projections.
Change propagation
Trace clause changes through mapped controls to impacted SOP versions and reassessment requests.
Reason before acting
Test hypothetical mutations against a frozen baseline with the Compliance Digital Twin.
Executive posture
Use deterministic KPIs, trends, data-quality indicators and a versioned compliance posture score.
Designed to coexist
Aurexios sits above the systems you already trust.
Aurexios intentionally avoids replacing mature operational workflows such as SOP approval, training, deviation execution, CAPA approvals or electronic signatures.
Its integration layer normalizes inbound data, applies tenant-aware idempotency and request tracking, and publishes intelligence through traceable HMAC-signed webhooks.
eQMSCAPA · Deviations
DMSSOPs · Training
Other systemsValidation · Risk · CSV
↓
AUREXIOS
Compliance Intelligence Layer
Regulatory graph · canonical controls · coverage · change impact · AI intelligence · Digital Twin · governance · reporting
↑
Regulatory content & control sourcesFDA · EU GMP · ICH · PIC/S
Built for the next generation of compliance operations
Turn fragmented compliance data into a state your organization can measure, explain and simulate.
Keep your operational systems of record. Add the intelligence and reasoning layer they were never designed to provide.