OOS & OOT Investigation demo
Every result plotted inside its specification; click an out-of-limit dot and the Phase Ia lab check runs on the raw data before anyone writes a hypothesis. 1:15
What the demo shows
A QC lab solution for analysts that guides out-of-limit investigations and drafts the report.
The lab bench plots every reportable result inside its specification band, out-of-specification in red and out-of-trend in amber, with the investigation clocks below. When a result lands outside its limits, the agents read the run, the audit trail, the instrument, the standards and the analyst's training, and fill the Phase Ia checklist with a verdict and a source for each check; only then are hypotheses ranked and a test plan drafted. The QC supervisor decides, QA approves any invalidation, and the report is drafted with citations. A nightly trend watch flags out-of-trend stability results and repeated patterns.
Transcript
- OS & OOT Investigation guides QC labs through every out-of-limit result, from raw data to report.
- Failure investigations are among the most cited findings in FDA drug inspections.
- Every result sits inside its specification.
- Red is out-of-spec, amber out-of-trend.
- At 8.02, a new impurity result lands above the upper limit.
- Click it, and the Phase Ia lab check opens with the chromatogram.
- Agents check the raw data first.
- The blank shows the same peak, and the methanol is new.
- Only then do the hypotheses open.
- Diluent contamination 71%. LENA accepts the cited checks and sends the plan to QA.
- Every out-of-limit result starts with its raw data already checked.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.