Understanding the critical difference between AI assistance and Regulatory Intelligence
The question we have heard a lot since the webinar
As regulatory consultants and Authorised Representative, we’re increasingly asked: “Why can’t we just use ChatGPT or other general AI tools for our regulatory questions? They’re free and seem to know about regulations.”
It’s a fair question that reveals a fundamental misunderstanding about what regulatory compliance actually requires.
The reality check
Here’s a question every regulatory professional knows: “Where did this requirement come from?”
With general AI tools, your response becomes: “AI suggested it. Here’s a link”. This isn’t acceptable in any regulatory environment. With purpose-built Regulatory Intelligence, you can respond: “Per ISO 13485:2016, clause 7.3.4”. Complete with document reference and exact citation.
The hidden risks of general AI in regulatory work
Source uncertainty: General AI tools rarely provide specific document citations. When they do, the sources may be outdated, irrelevant, or simply incorrect.
Knowledge contamination: Training data includes everything from blog posts to outdated guidance documents. There’s no quality control over what regulatory “knowledge” these tools have absorbed.
Hallucination risk: General AI can confidently present requirements that don’t exist or mix elements from different standards inappropriately.
What Regulatory Compliance actually demands
Traceability: Every compliance decision must be traceable to specific regulatory documents and clauses.
Source validation: The regulatory documents referenced must be current, applicable, and authoritative.
Consistency: Interpretation of requirements must be consistent across teams and over time.
Accountability: There must be clear ownership and justification for compliance decisions.
The professional standard
As regulatory professionals, we’re held to a standard that General AI simply cannot meet. Our role involves interpreting complex, interconnected regulatory requirements where accuracy isn’t just important – it’s legally mandated.
When stakes are high (product approvals, market access, patient safety) “AI suggested it” doesn’t provide the reliability that regulatory compliance demands.
The right tool for the right job
This isn’t about avoiding AI. It’s about using the right AI for regulatory work: purpose-built tools that understand regulatory document relationships and provide exact source citations.
The bottom line
General AI tools are excellent for brainstorming, drafting, and research. But regulatory compliance requires Regulatory Intelligence: AI that’s specifically designed for the unique demands of standards interpretation, cross-referencing, and audit-compliant documentation.
The question isn’t whether to use AI in regulatory work. It’s whether to use AI that meets the professional standards our industry demands.
As regulatory experts, we’ve seen the difference that proper Regulatory Intelligence makes in compliance accuracy and audit readiness. The investment in purpose-built tools pays for itself in reduced compliance risk and improved audit outcomes.