# Context of use: one page per AI tool

Fill this in before a tool is used on any analysis. Keep it to one page.

| Item | Your entry |
|---|---|
| Tool and version or model | |
| Owner (accountable person) | |
| Purpose: what is it for? | |
| Tasks allowed | |
| Tasks excluded | |
| Data it may see (and may not) | |
| What happens if its output is wrong? | |
| Review level (one reviewer, two, sampling) and why | |
| Evidence kept for every use (prompt, output, reviewer, data version, replay) | |
| Known limits and failure modes | |
| Approver and date | |
| Next review date and triggers (model change, package change, data change) | |

## Notes

- Scale the review level to the risk: exploratory work needs less than a primary analysis.
- Decide with your QA group which AI-related records fall under 21 CFR Part 11, and write the decision down.
- This is a template, not regulatory advice. Adapt it to your SOPs and check the official FDA and EMA texts.