CMCfyInvestigation Studio
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1 · Event

Example investigation loaded. It contains deliberate gaps so you can see the alerts.

2 · Original result

3 · Phase I: laboratory investigation

4 · Retest and resample

5 · Phase II: manufacturing investigation

6 · Root cause

7 · Impact on other batches

8 · CAPA

9 · Disposition and closure

Investigation outcome

–

Results against limits

Alerts to resolve

CAPA plan

Word report

The report follows 21 CFR 211.192, the FDA guidance on investigating OOS results (2022) and ICH Q10: event, Phase I and Phase II investigation, root cause, impact on other batches, CAPA, disposition, resolved alerts and blank sign-off lines.

Outcome rules follow the FDA guidance Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (Rev. 1, 2022): an original result is invalidated only with a documented, confirmed assignable laboratory cause; passing retests alone do not overturn an OOS result; the number of retests must be set in advance; and the investigation extends to other batches that may be affected (21 CFR 211.192). This is a draft for review by a qualified person.