GenAI Prompts: Navigating Validation in a QMS World

Generative AI (GenAI) is making waves across industries, but for regulated spaces like medical devices, it comes with a big question mark: How do we ensure the quality and reliability of GenAI-driven processes within a Quality Management System (QMS)?

This isn’t just about validating the AI itself, it’s about the often-overlooked piece of the puzzle: the prompts. Yes, the simple instructions we feed into GenAI systems can have a direct impact on quality outcomes, especially in FDA-regulated environments. Enter Computer Software Assurance (CSA), a risk-based approach that helps us focus validation efforts where they matter most.

The Core Question: Is It About the System, or the Prompt?

Here’s the crux: Should we be validating the GenAI system, the prompt, or both? While traditional software validation zeroes in on the system, GenAI flips the script. The prompt, those carefully crafted instructions, can change the output dramatically. That makes it a critical piece of any QMS process involving GenAI.

Why Prompt and Process Validation Matter

So, why bother with prompt validation? A few key reasons:

• 21 CFR 820.70(i): The Regulatory Reality Check This FDA regulation requires software validation for production and quality system use. If GenAI is reviewing QMS documents based on specific prompts, those prompts become part of the software’s “intended use.” Translation? They’re squarely in the validation zone.
• QMSR/ISO 13485: All About Processes and Risk ISO 13485 doesn’t explicitly shout “software validation,” but it’s big on process validation. Since GenAI is part of the QMS process, its prompts, critical inputs, deserve scrutiny. Are they consistent? Suitable? Reliable?
• Software Embedded in Processes: No Hiding Here Think of GenAI as not just a tool but part of the process itself. Under QMSR, process validation is key. If GenAI is involved in quality-impacting decisions, the software, and yes, the prompts, are in the spotlight.
• Impact on Decision-Making: The High Stakes When GenAI influences QMS document decisions, there’s no room for ambiguity. Poorly crafted prompts can lead to misleading outputs, which can ripple through quality decisions. That’s why validation isn’t just a box to check, it’s a safeguard.

What About Less Validation? Enter the "Fully Verified Process"

Now, some might argue: If every GenAI output is independently reviewed and approved by a human, do we really need to validate the prompts? This is the "fully verified process" argument. In theory, if human review is robust enough, it could reduce the need for exhaustive prompt validation.

But here's the catch:

• The human review process must be well-defined, documented, and consistent.
• Reviewers need proper training and qualifications to catch potential AI slip-ups.
• Without a strong review framework, relying solely on human oversight can become a weak link.

The Risk-Based Approach with CSA: Smart Validation

This is where CSA shines. It helps tailor validation efforts based on risk, not just rigid checklists. Here's how:

• Risk Assessment of GenAI Prompts Start by understanding the intended use. Is the prompt reviewing critical regulatory documents or generating low-risk content? Identify potential hazards (like vague prompts leading to misinterpretation) and assess the associated risks.
• Validation Activities Based on Risk High-risk prompts? They might need thorough testing and documentation. Lower-risk prompts? Simpler checks could suffice. CSA encourages focusing resources where they matter most.
• Strengthening the "Fully Verified Process" If you're leaning on human review to reduce prompt validation, CSA principles can help. Define reviewer qualifications, training protocols, and documentation standards to show that the verification process is solid.

Key Takeaways: Recommendations for Moving Forward

1. Conduct a Thorough Risk Assessment (Guided by CSA): Identify risks tied to GenAI prompts, focusing on their impact within the QMS.
2. Define and Document Processes Clearly: Outline how GenAI and prompts are used and document the human review process.
3. Integrate Prompt Considerations into Validation: Include prompt design, testing, and consistency checks as part of the overall validation strategy.
4. Establish a Robust Human Verification Procedure: Ensure human review steps are clear, documented, and supported by trained personnel.
5. Document Justifications with CSA Integration: Provide a clear rationale for your validation approach, supported by risk assessments and CSA principles.

In summary, while GenAI brings exciting possibilities to QMS processes, it also introduces new validation challenges. By applying CSA principles, organizations can manage risks effectively, ensuring both compliance and efficiency in their GenAI-driven quality processes.

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References:

1.???? Draft Guidance: Computer Software Assurance (CSA) for Production and Quality System Software, FDA, 2022 (link)

2.???? 21 CFR.820.70(i) Production and process controls - Automated processes (link)

3.???? Quality Management System Regulation (QMSR): Final Rule Amending the Quality System Regulation (link)