FDA ELSA · 21 CFR Part 11 / 111 · FSMA 204

Will your software stack survive an AI-targeted FDA inspection?

The FDA's ELSA generative-AI tool risk-scores facilities and drives one-day screening inspections, prioritizing sites with fragmented data, weak audit trails, and aged CAPAs. This tool scores your current stack against BatchBuddy's four GMP Native criteria and names the structural gaps ELSA is built to surface.

1 Your current software stack

Toggle every system your facility actually relies on to run and document a batch. Add anything that is the system of record for a step.

2 GMP Native maturity (self-assess)

Each pillar auto-fills from your stack. Adjust any level to reflect how it really runs on the floor.

3 Aggravating factors

ELSA escalates facilities with these conditions. Toggle any that apply.

Audit-Readiness Score

Select your stack to begin

ELSA exposure: pending Build your stack to see how FDA’s AI inspection-targeting would view it.

Structural gaps ELSA may flag

Remediation priority

Ready to close these gaps?

BatchBuddy is the only GMP Native™ platform purpose-built to enforce every control this tool measures — automatically, in a single audit chain, with no duct tape between systems.

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