Our methodology
Structured. Defensible. Inspection-ready.
A risk-based assurance methodology built for regulated environments — where inspection readiness, governance transparency, and decision accountability are non-negotiable.
Regulation-first interpretation
Evidence-based assessment
Human-governed determinations
Methodology principles
Grounded in regulatory expectations
Five core principles that govern every assessment, finding, and recommendation we produce.
Regulation-first interpretation
Every analysis is anchored in the primary legal mandate. All remediation strategies are built on a bedrock of current global regulatory standards.
Evidence-based assessment
We move beyond theoretical observation to forensic verification — using hard data and physical proof to identify GAPs and justify every proposed remediation path.
Risk-prioritised focus
Findings are triaged by regulatory impact and business urgency — neutralising critical threats immediately while building a sustainable roadmap for long-term stability.
Human-verified determinations
Every compliance determination made within the platform follows a human-governed workflow. AI surfaces and drafts — qualified reviewers confirm. Expert sign-off is available on demand.
Inspector-explainable outputs
Complex technical data is transformed into transparent, traceable documentation — designed to provide the clear justification and proof of logic that auditors demand.
Global regulatory reach
FDA · EMA · MHRA · SAHPRA · TGA · WHO · ICH — with assessors who understand the cultural and procedural expectations of each jurisdiction.
The assurance framework
Five stages. One inspection-ready outcome.
Each engagement follows a consistent framework tailored to scope, regulatory context, and organisational maturity. Click any stage to expand.
1
Scope & regulatory context definition
Define assessment scope, applicable regulatory frameworks, systems, processes, and operational boundaries.
What happens
Regulatory requirement mapping across all applicable jurisdictions
Operational boundary definition across systems and processes
Engagement scope document agreed and signed off
AI vs Human
AI accelerates cross-referencing of regulatory clauses
Platform workflow requires human confirmation of applicability
Scope document signed off within the platform before assessment begins
2
Evidence & control review
Structured review of documentation, records, system controls, and operational practices using evidence-based techniques.
What happens
AI-assisted analysis of controlled documents at scale
Audit trail configuration and system control review
ALCOA+ alignment scoring across all data touchpoints
AI vs Human
AI flags anomalies, version mismatches, and ALCOA+ gaps
Every flagged item reviewed by a qualified assessor
No finding enters the register without human confirmation
3
GAP identification & risk evaluation
Identify compliance gaps and evaluate risks using structured criteria — considering impact, likelihood, and detectability.
What happens
GAP classification by severity — Critical, Major, Minor
Risk scoring by regulatory consequence and business impact
Finding register populated in client portal
AI vs Human
AI identifies patterns and surfaces candidate findings
All risk classifications confirmed by qualified human assessors
AI never classifies severity — humans classify severity
4
Advisory remediation strategy
AI generates structured corrective actions for each finding. Your team reviews, responds, and uploads evidence directly in the platform.
What happens
Corrective actions generated for Critical and Major findings
Remediation sequence prioritised by risk impact
Actions assigned to client team with due dates
AI vs Human
AI drafts action descriptions and evidence requirements
Qualified consultants review and sign off all recommendations
Strategic sequencing determined by human expertise
5
Reporting & executive readout
Deliver inspection-ready reports designed for executive understanding and regulator explainability.
What happens
Executive summary for board and investor audiences
Technical package formatted for FDA, EMA, and global health authorities
All outputs delivered to client portal with full audit trail
AI vs Human
AI assists with structuring and cross-reference consistency
All compliance conclusions confirmed by qualified assessors
Human sign-off required before any report is published
Governance model
Accountability built into every step
The RelyAInt platform operates under a strict governance model to ensure accountability, traceability, and regulatory defensibility at every stage of your team's workflow.
Decision accountability
Platform workflow requires human confirmation of regulatory applicability
Human confirmation of all GAP conclusions before findings are published
Documented evidence linkage for every finding in the platform
Review and sign-off checkpoints enforced at every stage
Evidence & risk handling
Evidence confidence level considered for every finding
Risk-based sampling — not exhaustive, but defensible
Absence of evidence is not treated as absence of risk
Risk justification documented and traceable
What this means for your team
Your employees run assessments, review findings, and manage actions directly in the platform
Inspection-ready deliverables generated at every stage
Transparent decision-making your team can explain to an inspector
Expert review available on demand when your team needs it
Built for speed
Upload your evidence and your team can complete a full assessment within 48 hours
Findings, actions, and reports generated automatically — no waiting on external consultants
Progress tracked in real time in your client portal
Expert review escalation available on demand — response within 24–48 hours
AI usage boundaries
AI is advisory only.
Human governance is mandatory.
Human governance is mandatory.
AI tools accelerate analysis, drafting, severity classification, and pattern detection. Your team reviews and confirms every AI determination before it is published. No output leaves the platform without human sign-off.
AI accelerates the full assessment workflow
Reviews documents, flags anomalies, assigns severity and risk classifications, and drafts corrective actions — your team confirms each one
Your team governs every determination
AI-assigned severity and risk classifications are reviewed and confirmed by your qualified employees before any finding is published
Expert escalation available on demand
When your team needs additional assurance, a RelyAInt expert can review any finding or report — requested directly from the platform
EXPERIENCE THE METHODOLOGY
See it working in real time.
Try the compliance engine on our homepage — describe your
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