Cato AI
Cato AI, your own inspector.
He arrives, states his scope out loud, walks your records the way a surveyor does, and writes observations that cite what he saw. By appointment only, on your own records, before any of it counts.
One inspection, about twenty-five minutes
You do not prepare for Cato. You open the door and watch him work.
- 0 min
Opened
Cato states his scope before touching a record: how many items this workspace can evidence, and the 22 a real inspection covers that no software holds.
- 3 min
The walk
Five domains in a surveyor's order: licensure and procedures, the rooms, the compounders, hazardous drugs, the lot and supplier records. Requested and examined one at a time, while you watch.
- 11 min
An observation
Written the way a real one is written: what was asked, what was found, the record it rests on, and the date math shown rather than asserted.
- 16 min
Raised, not scored
Aseptic technique is watched by a person, never read by software. Cato raises it, says what will be asked and what a good answer looks like, and refuses to grade it.
- 21 min
Closing
The counts stated plainly, a document issued with the requested-but-not-held items listed by name, and a clock started: real inspections expect a written response.
- 25 min
Your response
Cato found it; Vera already drafted the answer. The name and the date are yours to add, because a commitment with nobody's name on it is worth nothing.
Stating the scope, including what is out of it.
Sample workspace. A rehearsal is practice on your own records, never a prediction of any board's or agency's findings.
Local sample data. Not a live account. Every supplier, lot, order, and document shown here is fictional.
The agent wave, with receipts
You have read a year of promises about AI agents. Here are two with jobs.
Vera works your desk every day; Cato inspects by appointment. Both have names, both show their work while it happens, and both publish the exact lines they stop at. Not a copilot, not a chat window: a quality team whose every action carries a receipt and whose every refusal carries a reason.
What makes an agent real
- Named. Work signed by the agent that did it, never by a vague system.
- Visible. The walk plays in front of you; nothing happens off screen.
- Limited. The refusals are published, in product and on this site.
- Receipted. Every observation cites the record it rests on.
What he does
An inspection, not a report.
A report generator returns a sorted list. An inspector arrives, requests, notices what is not produced, and leaves you something to answer. Cato does the second thing.
States the scope first
Before touching a record he announces the plan and the honest denominator: what he can examine here, and what a real inspection covers that he cannot.
Requests records one at a time
The walk is watchable: each domain moves from queued to requesting to examined, in the order a surveyor's requests actually arrive.
Writes observations like the real thing
Clear, specific, and cited: the ask, the finding, the record it rests on, and the dates shown. Never a score with no sentence behind it.
Raises what no software holds
22 requests he cannot answer, raised with what will be asked and what a good answer looks like, and never counted for or against you. The full list is published below.
Issues a document that starts a clock
The inspection record, issued as a file, with the requested-but-not-held items listed by name. Real inspections expect a written response; so does he.
Remembers your answers
An observation that comes back after your own written response is flagged in exactly those words, quoting your date and your named owner, because knowing and not acting is the most damaging finding there is.
What he will never do
An inspector you can trust is one who knows what he cannot see.
Every line here is structural, not a setting. The rehearsal is credible precisely because these do not move.
Score what he cannot see
The 22 items no software holds are raised and never graded. A rehearsal that scores only what it stores is a vendor grading its own homework.
Watch anyone compound
The most cited finding in the country is aseptic technique, observed by a person. No software sees it, and pretending otherwise would discredit everything else he says.
Predict an outcome
A rehearsal is practice on your records. It never forecasts what any board, surveyor, or agency will ask, find, or decide.
Borrow a regulator's words
He writes in his own vocabulary. Agencies' classification terms belong to their determinations, and he makes none.
Grade you to anyone else
The rehearsal is yours. Observations, responses, and history live in your workspace, for you, not as a score shown to anyone else.
Judge without an appointment
Vera, your teammate, never grades your mess. Cato judges only when you open the door, because your teammate should never be your grader.
The 22, published
Every question he refuses to score, in full.
A rehearsal that covers only what the vendor stores is a vendor grading its own homework. Here is everything a real surveyor asks for that lives outside any system: the ask as it will arrive, and what a good answer looks like.
Zone A: evidenced here
The workspace holds the record. Cato examines it and cites it: the document, the date, the gap, in the shape a real observation takes.
Zone B: partly here
A fragment or a proxy exists. Cato examines what is on file and names exactly what is missing, rather than rounding a fragment up to an answer.
Zone C: not here at all
Physical, observed by a person, or in another system entirely. Cato raises these as requests he cannot answer, says what good looks like, and never scores them. The list below is that zone, in full.
Why the list matters
The most cited findings are things software never sees.
23%
of pharmacies were observed failing to maintain aseptic technique. Observed, by a person, watching. The most cited finding in the analysis.
NABP, published 213-inspection analysis
36 of 40
compounding pharmacies failed basic cleanliness standards in one state's unannounced sweep. Nothing in software sees a shelf.
Massachusetts board, unannounced inspection sweep
Sampled, then shelved
Pharmacies frequently sample on schedule and take no action on out-of-specification results; the missing action is what gets cited.
NABP, published 213-inspection analysis
Domain 1 of 5
Written procedures and the quality system
The paper spine of the operation: recipes, batch records, investigations. Most of it lives in your dispensing system or a binder, not in any oversight tool.
“Show me the Master Formulation Record for a preparation you compound regularly.”
A good answer: A written record per preparation: ingredients with amounts and sources, equipment, step-by-step method, beyond-use date and its basis, container closure, and labeling.
It is the recipe of record. Without it, two technicians can make the same preparation differently and nobody can tell.
“Show me the Compounding Record for the last batch you made.”
A good answer: A per-batch record naming who compounded, the lots of every component used, the yield, the checks performed, and who verified.
This is the link between a finished preparation and the components you can prove. Its absence breaks traceability in both directions.
“What beyond-use date do you assign this preparation, and on what basis?”
A good answer: The BUD, the specific USP category or stability data it rests on, and the SOP that fixes the method.
BUD errors are among the most frequently cited findings, usually from inconsistent method rather than bad intent.
“Show me a finished label and the SOP that governs it.”
A good answer: Content required by your state, auxiliary and hazard labelling, and the review step that catches errors before dispensing.
“Show me your last deviation, its investigation, and the corrective action you took.”
A good answer: A written investigation with a root cause, a corrective action, a due date, and evidence it was completed and effective.
A serious inspector digs here, because it shows whether your quality system is a habit or a binder.
“Show me the complaint and adverse-event log and one closed investigation.”
A good answer: A log with dates, the investigation, the conclusion, and the corrective action, closed on a stated timeframe.
“Show me current licenses for every pharmacist and technician working today.”
A good answer: Each individual license with its expiry, current, and a process that catches a lapse before it happens.
Facility registrations and individual licensure are different files; inspections ask for both.
Domain 2 of 5
The rooms and their engineering controls
Cleaning, temperatures, pressures, and what you did when a number went wrong. The logs are physical, the rooms more so.
“Which agent do you use on which surface, what is its required contact time, and show me the log.”
A good answer: The agent, its label contact time, the cleaning frequency per area, and a signed log matching that frequency.
Wrong agent, wrong contact time, or a missing log is among the most cited findings in the country.
“Show me refrigerator and freezer temperature records for the last 90 days, including any excursions.”
A good answer: Continuous or twice-daily records, alarm limits, and a written response for every excursion with a disposition for the stock involved.
“Show me the daily pressure differential readings between your anteroom and buffer room.”
A good answer: A daily record within your stated limits, with an action taken whenever it fell outside them.
“Your last out-of-specification environmental result: what did you do about it?”
A good answer: The investigation, the genus-level identification the 2023 revision requires at action levels, the corrective action, and the verification sample proving it worked.
Inspectors report that pharmacies often sample on schedule and then do nothing about the result. The action is what gets cited, not the sample.
“Walk me through the compounding area.”
A good answer: Clean, uncluttered surfaces, correct storage and segregation, no expired stock, working sinks and eyewash, and hazardous areas physically separated at negative pressure.
In one state's sweep, 36 of 40 compounding pharmacies failed basic cleanliness. Nothing in software sees a shelf.
“What water do you use for compounding, and how do you know it meets the requirement?”
A good answer: The water type per preparation and the record that supports it.
Domain 3 of 5
The compounders, watched
The most cited findings in the country are in this domain, and every one of them is a person watching a person. No rehearsal can substitute.
“I would like to watch someone compound.”
A good answer: Correct hand hygiene, correct garbing order, no first-air interruption, correct disinfection of every entry into the ISO 5 space, and unhurried technique.
The most cited finding in the country: 23% of pharmacies in NABP's 213-inspection analysis were observed failing to maintain aseptic technique. This is watched, never read.
“Show me your hand hygiene before garbing.”
A good answer: The full procedure, in order, without shortcuts, matching your own SOP.
“What is your personnel health and exposure programme for hazardous drugs?”
A good answer: PPE requirements per activity, a spill procedure with a stocked kit, and a documented exposure response.
Domain 4 of 5
The hazardous drug program
Storage, waste, and the physical separations. Verified by standing in the room, not by reading a file.
“Show me the hazardous drug storage, the negative pressure, and the spill kit.”
A good answer: Segregated storage, verified negative pressure, a stocked spill kit within reach, and staff who know where it is.
“How is hazardous drug waste segregated and disposed of, and by whom?”
A good answer: The waste streams, the containers, the licensed vendor, and the manifests.
Domain 5 of 5
Controlled substances, security, and dispensing records
These live in your dispensing system, your DEA records, and your building. An oversight layer holds the evidence chain for the lot; these are the neighbouring files it does not hold.
“Show me your perpetual controlled-substance inventory and a reconciliation.”
A good answer: A running count reconciled on a stated cadence, with every discrepancy investigated and documented.
“Show me your DEA 222 forms or CSOS records for the last year.”
A good answer: Complete, in order, matched to receipts.
“Show me how the pharmacy and its controlled substances are secured.”
A good answer: Access control, alarm coverage, camera retention, and a list of who holds keys or codes.
“Pull the prescription record for a specific patient and preparation.”
A good answer: The prescription, the compounding record it triggered, the label, and the dispensing record, retrievable in minutes.
The lot's evidence chain and your dispensing system's patient records are different systems, and an inspection walks the join between them.
Your part
The work you do is minutes, and it is the part that matters.
Everything mechanical is his: the requests, the examination, the citations, the document, the reminders. What remains is exactly the part that should never be automated.
- Open the door. One click starts the inspection; you can watch or walk away.
- Read the observations. Each one is a sentence with its evidence attached, not a dashboard to decode.
- Sign the responses. Vera drafts them where she can; the owner and the date are always yours to add.
- Answer the 22 out loud. The published catalog tells you what will be asked and what good sounds like, before it is asked in person.
Two agents, one firm
Cato finds it. Vera drafts it. You sign it.
The inspector and the quality team share one case file: an observation raised on the walk arrives with a drafted response beside it, waiting for a name and a date. An inspection that ends with drafted answers instead of homework is the whole point of having both.
What Cato is not
Cato examines documentation. He does not test medicine, observe technique, enter your rooms, or make any safety, quality, efficacy, legality, or approval claim about any preparation or facility. A rehearsal is not an inspection, does not predict one, and does not substitute for one. The catalog above is homework, not advice: it does not state or predict what any board, surveyor, or agency will ask or decide.
Open the door. He is ready now.
The live demo runs the whole choreography on a real workspace: the walk, the observations, the document, the response loop. No signup.