AI incident reporting for pharmaceutical CDMOs

Anyone on site calls and says what happened, in English or Urdu. The agent puts people's safety first, gives the immediate measures from your own rules, takes the first information report, sets the severity and says who must be told.

Solvent spill: Try: "About 2 litres of methanol spilled in granulation room 3."

Potent compound spill: Try: "A drum of an OEB 4 API powder tipped over in the dispensing booth."

Splash or injury: Try: "A colleague got cleaning solution in his eye."

Clean room or storage excursion: Try: "The cold room for client material read 12 degrees this morning."

Mix-up: Try: "We found the wrong batch label on two drums in the warehouse."

Near miss: Try: "A forklift nearly hit someone at the loading bay."

1. Safety first: It asks whether everyone is safe. Anyone in danger is told to raise the alarm and call the site emergency number.

2. Immediate measures: It gives the first measure for that incident from your site's rules: isolate, no ignition sources, eyewash, quarantine.

3. First information report: Who, what, where, when, which material and how much, people affected, actions taken and product impact.

4. Severity and routing: It sets the level, says who must be told now, and reads the report back to confirm it.

People before paperwork: It takes the report only once people are safe.

Never says it's safe: Only EHS says an area can be re-entered or a spill is clean.

Potent compounds: Only the trained spill team cleans up an OEB 4 or 5 spill. Nobody sweeps or uses compressed air.

Only your measures: It never gives a cleaning, neutralising or medical method that isn't in your rules. Otherwise: SDS and spill SOP.

Client material flagged: If a client's batch may be affected, QA decides whether the client must be told under the quality agreement.

No blame, no guessing: It never blames anyone or guesses at a cause. The investigation finds it.

Your rules loaded: Your emergency plan, spill and deviation SOPs, SDS list, potency bands and quality agreement notice rules, reviewed by EHS and QA.

Reports in your system: The first report sent straight to your deviation or EHS system, or by email, with Level 3 alerts by phone or text.

Trends: Incidents and near misses counted by area and type, so CAPA effectiveness can be tracked.

Anyone can call: One number posted in every area, answered at any hour, in Urdu and English.