Applied AI for regulated and quality-critical operations

AI that earns its keep.

Most AI hands you an answer and leaves you to trust it on faith. This practice designs every system so the answer carries its evidence -- source, version, and provenance -- and so it earns its place in real, everyday work.

Citation-traced Eval-loop verified Review-gated

The session fee is credited toward any engagement you take forward.

BSEE / MBA / PMP 100+ regulated facilities Production RAG SaaS -- Medicare/Medicaid, live at cmslookup.com 20+ years food, pharma, hospital OR, battery dry rooms
01The failure mode your vendor will not describe

A hallucination in a controlled document is not a chatbot problem. It is a quality event.

The risk of industrial AI is not that it fails visibly. It is that it fails quietly -- a fabricated citation in a batch record, a confident wrong answer in a regulatory submission, a system no one is evaluating because it shipped as a proof of concept and never got a finish line. Most vendors do not have a plan for that. They have a demo.

RISK 01

Ungoverned outputs reaching controlled documents

When an AI system cannot trace its answer back to a source -- with version and provenance -- you cannot prove it was right, and you cannot prove it was wrong. In a GMP environment, that is a documentation failure waiting for an investigator.

RISK 02

Pilots that end as experiments, not value

Around 70% of AI pilots in small and mid-size operations stay in the experimental phase. The missing ingredient is scope, acceptance criteria, and someone accountable for the finish line.

RISK 03

Advice from people who have not shipped anything

Most AI consultants have not run a production AI system inside a regulated business. They are selling a methodology that has not been pressure-tested where a data failure is a real liability.

Start here

The State of AI Session.

Most decision-makers picture a chatbot. The real value in an operation like yours is somewhere else -- retrieval over your own documents, generated paperwork, systems that monitor and check themselves. In one focused hour we evaluate your operation together, and you leave with a written, leadership-ready snapshot of where AI creates defensible value and where it does not -- whether or not we work further. Structured and run the same way every time, because a process you can see is a process you can trust.

0:00
FrameWhat we'll cover and what you leave with. Ground rule: no pitch.
0:05
MapA standard question set across your workflows and documentation landscape to find where time, error, or exposure concentrates.
0:25
Joint evaluationWe complete the AI Readiness & Opportunity scorecard on screen, together -- data readiness, workflow fit, risk/compliance exposure, team capacity, integration surface.
0:45
Guardrails & reality checkWhere AI does not fit, where provenance and review gates are mandatory, and the data-security posture.
0:55
Next stepIf there's a fit, a managed path forward -- this fee credited. If not, you still keep the snapshot.

What you walk away with

  • A written, leadership-ready State of AI Snapshot (within 48 hours)
  • Your readiness scorecard across five dimensions
  • Your top 2-3 AI opportunities, ranked, with risk flags
  • The provenance and review-gate requirements for each
  • A recommended first step -- yours to act on, with or without me
$500credited toward any engagement · starts with a free 15-min fit check
Request your fit check
02Where the session leads

One practice. Four ways to apply it.

The session points to whichever fits -- a structured assessment, a system built to spec, an ongoing technical partner, or training. Every path is scoped, reviewed, and managed to a defined outcome.

State of AI Session$500, credited
01
AI Opportunity Assessmentfixed fee
02
AI Build Sprintfixed scope
03
Fractional AI Advisorretainer
04
The front door

AI Opportunity Assessment

The fuller version of the session: where AI creates defensible value, the data-provenance and review-gate requirements, and what a managed build path looks like.

Fixed fee · 2–3 weeks · session credited
The build

AI Build Sprint

Design and build with traceability and evaluation in the architecture from the start. Delivered to defined acceptance criteria.

Fixed-scope project
Ongoing

Fractional AI Advisor

A technical partner who runs the practice on your behalf -- roadmap, oversight, and an evaluation cadence that keeps live systems accurate.

Monthly · defined scope
Enablement

AI Workshops & Training

Hands-on training that gives your team the judgment to use AI safely in a quality-critical workflow -- where to trust it, where to gate it.

Half- or full-day
03Why this practice, specifically

Two things almost nobody combines.

Good AI guidance requires two kinds of credibility, and most practitioners have one: engineering experience in regulated, mission-critical environments, and actually having shipped production AI in one of them -- not a case study you read, but a system you built, deployed, and are responsible for keeping accurate.

  • 01Builds what he recommendsVerbatim (cmslookup.com) is a live, paying-customer RAG SaaS for Medicare/Medicaid billing -- citation provenance, sha256-hashed source snapshots, an SME evaluation loop. Every answer traces to its source, because the domain required it.
  • 0220+ years in environments that do not forgive errorsFood processing, pharmaceutical manufacturing, hospital operating rooms, lithium-battery dry rooms, cold storage -- 100+ facilities. Where the instinct that a claim needs to be traceable was developed.
  • 03Engineering QA is a process step, not a preferenceThe content pipeline runs psychrometric verification as a discrete checking step. That produced 14 application guides that hold an engineering quality bar. Evaluation is built in, not bolted on.
  • 04MBA and PMP discipline applied to adoptionScope, risk, review gates, and acceptance criteria are why a pilot reaches production instead of dying in a conference room. The 70% that stall are project failures, not software failures.

I built Verbatim so every answer traces back to its source because the domain demanded it. Version, hash, provenance, on every answer. That is not a feature. That is the minimum the work required.

-- Mike Harvey, BSEE / MBA / PMP · Founder, Harvey Consultancy
Exhibit: source provenance -- sha256-verified snapshot, Verbatim v1
04Systems in production, not proposals on a slide

Proof that exists before you become a client.

The practice runs several AI systems in live environments right now. The best evidence that a method works is that it is running.

AI engineering -- built and operating

Each system is live and in use.

Descriptions follow the evidence on file. Nothing here is aspirational.

  • Verbatim / CMS Lookup (cmslookup.com) -- a production RAG SaaS for Medicare/Medicaid billing with citation provenance, source snapshots, and an SME evaluation loop. Paying customers.
  • Multi-step AI content pipeline -- researches, drafts, and quality-checks technical content with psychrometric verification as a discrete QA step. Produced 14 application guides.
  • RAG knowledge system -- over a proprietary engineering library. Instant, sourced answers from decades of material.
  • Real-time AI phone agent -- telephony integrated with model reasoning to qualify and handle inbound calls.
  • Scheduled monitoring agents -- watch defined sources and report changes without a person watching the feed.
  • Multi-agent orchestration -- defined roles, hand-offs, and review gates. Whole workflows, not single prompts.
RAG / retrievalCitation provenanceEval loopsMulti-agentAutonomous agentsRegulated environments
Industrial dehumidification -- 20+ years

The credibility that makes the method believable.

Grounded in deep technical operations experience where documentation and data accuracy are not optional.

  • Engineered desiccant and hybrid desiccant-refrigeration systems across food, pharma, hospital OR, battery dry rooms, and cold storage -- 100+ facilities worldwide.
  • BSEE, MBA, PMP. Applications engineering, system design, field troubleshooting, and operations leadership.
  • Co-founder, Desiccant Air Solutions. Founder, Harvey Consultancy LLC (2022). Global clients across Europe, Japan, Singapore, Taiwan, and North America.
  • Native fluency in GMP compliance, documentation discipline, uptime requirements, and the cost of getting it wrong.
My dehumidification background →
[ product screenshot -- cmslookup citation + provenance panel ]
Exhibit: source provenance, cmslookup.com (live)
Where the work lives

Built for mission-critical environments.

Two decades engineering humidity and air control across food processing, pharmaceutical manufacturing, hospital operating rooms, lithium-battery dry rooms, and cold storage.

Industrial process plant interior
Stainless steel process piping
Clean facility interior
Industrial hall with overhead cranes
05A codified process, not a guess

The same repeatable path, every engagement.

From the first paid hour to a commissioned system, the sequence is structured, reviewed, and managed -- the way a regulated build should run. You always know what comes next.

Free fit check
$500 -- credited
State of AI Session

The paid hour. We map and evaluate your operation together; you leave with a written snapshot.

Assess

Opportunities evaluated against your constraints -- data quality, regulatory needs, review-gate requirements. A prioritized scope with acceptance criteria.

Build

Design and build with traceability and evaluation in the architecture from the start, not added later.

Sustain

Commission with documented baselines and a defined evaluation cadence. Someone is watching, systematically.

Improve

The scorecard and the systems get sharper with every run. The process compounds.

MH
About

Mike Harvey

I am Mike Harvey -- BSEE, MBA, PMP, and founder of Harvey Consultancy LLC. I spent 20+ years engineering desiccant and hybrid desiccant-refrigeration systems in regulated and mission-critical operations: food processing, pharmaceutical manufacturing, hospital ORs, lithium-battery dry rooms, cold storage. That work taught me that a system which cannot prove its answer is not a working system. I brought that standard to AI.

I built Verbatim -- a live, compliance-grade RAG SaaS for Medicare/Medicaid billing -- not as a demonstration, but as a product with paying customers who depend on its accuracy. I also run a multi-agent AI content pipeline, a retrieval-augmented engineering knowledge system, an AI phone agent, and autonomous monitoring agents. I advise on AI the same way I built those systems: scoped, reviewed, traceable, and managed to a finish line.

Harvey Consultancy LLC -- Grand Island, NY. Clients in North America, Europe, Japan, Singapore, and Taiwan.

Start with one structured hour.

The State of AI Session gives you a written, leadership-ready picture of where AI creates defensible value in your operation -- and what a managed, traceable build would require. It starts with a free 15-minute fit check, and the $500 fee is credited toward any engagement you take forward.

Request a session

mike.harvey@harveyconsultancy.com  ·  harveyconsultancy.com