Complaint and Investigation Desk

Fernhollow Botanicals

One gritty tin is a replacement. Three on one lot is an investigation.

Twelve contacts arrived this week as email, web forms, retailer notes and transcribed calls. The agent reads each one, qualifies it in the words the complainant used, and hands the rest to the code: the urgency follows the defect category, the due date follows the qualification, the trend is counted per lot and per defect category, and the investigation only opens on a trigger the counter actually established. It never says how serious an adverse event is. It cites the rule that says who does.

Measured here, end to end on the whole queue: run one and watch. That covers intake qualification, the QMS record pre-fill, the trend count and the investigation record. It does not sample, does not inspect a returned unit or a retained sample, does not review a batch record on the floor and does not close anything.

What this shows

The problem
Complaints arrive as free text through four channels. Somebody has to qualify each one the same way every time, pre-fill the QMS record from what the contact actually said, notice the three that share a lot, and open an investigation before the pattern reaches the annual report.
The result
The run below is real and is recorded: twelve contacts qualified, the urgency, the due date and the routing computed from the procedure, the trend counted per lot and per defect category, and every line carrying the reference it came from.
What is simulated, and what is not covered
The maker, the twelve contacts, the six lots, the laboratory report and the two internal procedures are invented. The two public rules are not: 21 U.S.C. 379aa and 21 CFR 211.198 are quoted verbatim with their source. There is no QMS connection, no ERP, no scanned document. Sampling, physical inspection and batch record review on the floor are outside this desk, and so is any determination of how serious an adverse event is.
What a pilot would need from your side
A sample of real complaints with the names removed, your complaint and investigation SOPs in whatever form they exist today, and one person who can say whether a qualification is right.
Who built it
Frederic de Lavenne de Choulot, The AI Pipe. Built as a demonstration, not sold as a quality or regulatory product.

Intake this week

Batch register

Procedures and rules

Enter to send, shift and enter for a new line. Live tool use over twelve contacts, six lots, two procedures and two public rules.