Do I need to do all of this for every LLM? No. The rigor scales with risk. A literature search assistant needs less than a deviation categorization tool that feeds your CAPA system.

Can you work with our existing validation SOPs? Yes. I map to GAMP 5 (2nd Edition) and CSA. If your team still files IQ/OQ/PQ, I provide a crosswalk.

What if we're just exploring? Start with the R&D Sprint. Get signal before committing to full validation.

Do you work with AI vendors or just end users? Both. I've helped companies validate third-party tools and supported AI vendors preparing for life sciences customers.