janyl

Staying compliant.

Agents made by janyl are deployed into multiple highly regulated industries, where they regularly perform internal audits.

An agent knows to never take anything at face value and explore all possibilities, not just the obvious ones. In this anonymized example from a medtech company, their agent FSM is able to diagnose a novel root cause behind an uptick of anomalies during an audit.

quality system nightly run

Internal audit

Non-conformities

Major
Was 2
Now 6
Minor
Was 7
Now 23
  • NC-018Design input traceabilitymajor
  • NC-019Supplier requalificationmajor
  • NC-021Training recordsminor
  • NC-022CAPA effectiveness checkminor

and 25 more

Marek D.

why did non-conformities jump from 9 to 29 overnight

FSM

The findings are real. The jump is not. The model the QMS names for non-conformity evaluation was decommissioned yesterday, so last night’s run fell back to the default one, which is stronger and catches more. Those twenty were always there.

Two things follow, and the order matters. The QMS still names a model that no longer exists, so that entry has to be corrected before last night’s run counts as evidence. Then the twenty stand on their own and go to CAPA.

Marek D.

oh wow I didn’t even realize that was a thing. this is terrible, what do we do now

FSM

I understand, and it looks worse than it is. Most of them are easy to fix. Twenty-three are records and traceability gaps, which close by supplying what is missing, and I can prepare all of those. Six need your judgement, not mine. I have started.

  • QMS model entry correcteddone
  • Minor findings, drafting corrections14 of 23
  • Major findings, routing to CAPAqueued

FSM is working