Regulated environments demand deterministic evidence for non-deterministic systems

GxP regulations require reproducibility, traceability, and deterministic outcomes. LLMs are probabilistic: the same input can produce different outputs across runs. This tension is the core challenge of deploying AI agents in pharmaceutical and biotech manufacturing.

The resolution is not to make the AI deterministic (you cannot) but to build deterministic evidence around it. Every agent (see: evals define what success means for an agent) output that feeds a GxP decision is an electronic record under 21 CFR Part 11, requiring audit trails, electronic signatures, and ALCOA+ data integrity. The eval suite proves the system works within defined parameters; the production trace proves it continues to work. The human reviewer signs off. The non-determinism is contained by the qualification framework, not eliminated.