A practical, risk-based framework for governing, assessing, assuring and managing the use of artificial intelligence within pharmaceutical Regulatory Affairs.
From AI risk to regulatory control to auditable evidence.
Enterprise AI governance can establish organization-wide expectations for inventory, risk, responsible AI, security, privacy, human oversight and monitoring. Regulatory Affairs must translate those expectations into the actual work performed in labeling, regulatory intelligence, submissions, controlled content, regulatory data and related workflows.
Establish accountability, policy, human authority, risk governance, vendor governance, documentation and traceability expectations.
Define the Context of Use, purpose, boundaries, stakeholders, technology context, risks, requirements and expected benefit.
Establish evidence that AI performs as intended within defined boundaries through measurement, testing, traceability, review and monitoring.
Prioritize and treat risk, manage incidents and change, address residual risk, escalate issues and govern continuity, suspension or retirement.
ASSURE is RA3F™'s adaptation of the NIST AI RMF MEASURE function for the Regulatory Affairs assurance context.
RA3F™ starts with the actual use of AI, not the technology label. The same underlying model can present very different regulatory risk depending on its purpose, users, inputs, outputs, workflow position, decision influence, human authority, boundaries and evidence requirements.
Lower regulatory consequence; proportionate controls and evidence.
Meaningful Regulatory Affairs influence requiring enhanced governance and assurance.
Higher-consequence use requiring formal control, assurance and decision evidence.
RA3F™ separates risk tier, risk priority and control intensity. Applicable controls are identified as CORE or CONDITIONAL, with Basic, Enhanced or Formal implementation intensity as appropriate.
RA3F™ is an integration layer. It is intended to work alongside enterprise AI governance, quality systems, security, privacy, legal, records management, vendor management, system assurance and existing Regulatory Affairs process controls rather than replace them.
GOVERN spans the entire lifecycle.
Consider an AI capability that compares an approved Prescribing Information document with a proposed revision and identifies omissions, unsupported claims, differences and traceability evidence.
Identify potential differences, findings and supporting evidence for review.
A qualified labeling reviewer confirms, rejects, modifies or escalates AI findings.
Authorized Regulatory Affairs personnel determine the regulatory action. AI assists; humans decide.
The objective is to make significant conclusions explainable, reviewable and supportable with evidence. RA3F™ distinguishes assurance, authorization and residual-risk acceptance: assurance informs the decision; it does not make the decision for the accountable organization.
A focused RA3F™ pilot can define the Context of Use, assess risk, identify applicable controls, establish assurance and evidence requirements, and provide an executive roadmap before broader implementation.
Download this complimentary working questionnaire to define how an AI capability is intended to be used within Regulatory Affairs, where it influences regulated work, what human oversight is expected, and what evidence and controls may warrant deeper assessment.
This is an initial scoping resource—not a certification, compliance determination, regulatory approval, or formal RA3F™ assurance conclusion.
The future assessment will be educational and preliminary. It will not determine regulatory compliance, certify an AI system, or replace qualified Regulatory Affairs, quality, legal, security or privacy review.
External Reference Qualification. RA3F™ incorporates concepts and practices informed by external regulations, guidance, standards and AI risk-management frameworks. References to NIST, FDA, ISO/IEC, ICH, EMA or other external organizations do not constitute endorsement, certification, approval or formal adoption of RA3F™ by those organizations. RA3F™-specific controls, risk tiers, control intensities, artifacts, terminology and assurance methodologies are defined by RA3F™ unless explicitly identified as originating from an external source.