Transform Manufacturing Quality
with Human-in-the-Loop AI Solutions
Every incoming lot ships with a COA. Every batch generates a 60-page record. Every defect spawns an NCR that sits open for three weeks while inventory stays quarantined. Your best QA people spend their days keying data into SAP and cross-checking PDFs against spec sheets instead of actually improving quality. We build AI tools that handle the document grind so your team can focus on the work that actually prevents FDA 483s and customer escapes.
* We walk your floor and scope the solution at no cost. No commitment until you see the plan.
Where It Actually Helps
These are the tasks that eat your QA team's week: reviewing COAs against spec sheets, walking batch records page by page, chasing NCR closures, and pulling production data for management reviews. Each one is document-heavy, error-prone, and directly tied to lot release timelines and audit readiness.
COA Verification & Processing
Every incoming lot ships with a COA — a PDF from the supplier listing purity, moisture, particle size, heavy metals. Your QA tech opens it, reads every line, manually checks each value against your internal spec sheet, and keys it all into SAP. Takes 30 minutes per COA, and one missed OOS reading on heavy metals is how you end up with an FDA 483. Our AI reads the COA in any format, extracts every test result, compares against your spec limits, and flags anything out of range — in under 2 minutes, with a full audit trail.
Batch Record Review
A batch record is 60-100 pages of in-process checks, equipment IDs, operator signatures, and test results. Your QA reviewer sits down with the master batch record and goes page by page: is every field filled in, is every signature present, does the mixing time on step 14 match the spec? Miss a blank field and the batch sits in quarantine. Miss a pattern and you get a deviation you should have caught. Our AI scans the entire record, verifies every data point against the master, checks all 12 signatures, and hands your reviewer a short exception report. Review time drops from 3.5 hours to 42 minutes.
Non-Conformance Report Management
You know the cycle: operator finds a defect, writes it up, someone in QA classifies it, someone else determines disposition, and the NCR sits open in MasterControl or TrackWise for three weeks while people argue about root cause. Meanwhile, 150 units sit in quarantine and your production schedule slips. Our AI auto-classifies the defect from the inspection report, searches your historical NCR database to flag repeat patterns (so you catch systemic tool wear before it becomes a CAPA), routes approvals, and helps close the NCR in 3 days instead of 22.
Your human inspectors start their shift at 84% defect detection. By hour six, they're worse. They miss the hairline scratch, the 0.15mm burr, the subtle discoloration — and those parts ship to your customer, who sends them right back with a supplier corrective action request. Our vision AI runs at 99.3% accuracy, every part, every shift, no fatigue. It classifies scratches, dimensional variances, and cosmetic issues at 1.8 seconds per part, at full line speed, and logs every result for your SPC data.
Production Data Queries (NL2SQL)
Your plant manager asks "What was OEE on Line 3 last week?" and someone files a ticket with IT. Three days later, an analyst writes a SQL query, puts the result in a spreadsheet, and emails it back. By then the problem has moved on. With NL2SQL, anyone on the floor types the question in plain English and gets the answer in under a second — scrap rate by shift, downtime by machine, yield by part number. Your MES and ERP are full of data. This is how your operations team actually uses it.
Built for Regulated Manufacturing
Full electronic records and signatures compliance. Audit trails, access controls, and tamper-evident logs that hold up during FDA inspection.
Aligned with QMS requirements for ISO 9001 and IATF 16949. We've been through the recertification audits — the system is built to pass them.
Certified security controls covering data handling, access management, and operational procedures.
Every extraction, comparison, and disposition decision is logged with timestamps, user IDs, and change history. When an auditor asks "who approved this lot release and when," the answer is one click away.
QA techs see COA results. Operators see batch status. Plant managers see dashboards. Nobody sees what they shouldn't. Integrates with your existing Active Directory or SSO.
Runs inside your plant network, behind your firewall. Your batch records, COAs, and production data never leave your facility. Air-gapped deployments available.
How We Work
We start on your plant floor, not in a conference room. From first walkthrough to production deployment in weeks, not quarters.
Discovery & On-Site Assessment
We walk your plant floor with your QA manager, process engineers, and maintenance leads. We watch how COAs get reviewed, how batch records move through the system, where NCRs get stuck. We quantify the labor hours, the quarantine days, the risk. You get a scoped proposal at no cost.
Approval & Development
Once you approve the plan, we build. We train the AI on your actual COA formats, your spec limits in SAP QM, your master batch records, your defect classification taxonomy. Not a generic model — one that knows your products, your suppliers, and your GMP requirements.
Integration & Testing
We connect to your SAP, MasterControl, Veeva, or whatever QMS you run — API-first, minimal disruption to production. Then we test against real batch records and COAs from your last three months. Every result is validated against 21 CFR Part 11, ISO 9001, and IATF 16949 requirements before we go live.
Go Live & Continuous Improvement
The system gets smarter with every COA it reads and every batch record it reviews. New supplier format? It learns it. Your QA team gets live dashboards showing throughput, exception rates, and disposition times — plus complete audit logs for your next FDA or ISO surveillance audit.
Stop Losing Weeks to Paperwork
Your QA team is spending 60% of their time on document review and data entry. Your NCRs sit open for three weeks. Your batch releases are bottlenecked by a two-person review team. We fix that — with AI tools built for the realities of GMP manufacturing, not a generic chatbot with your logo on it.