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AI Engineering for Quality & Compliance

We automate CAPA tracking, complaint management, and audit documentation — your quality team investigates root causes, not fills out forms.

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What We Automate

We don't know every problem in your operation. You do. These are the types of work we engineer AI for. You tell us where it hurts most.

Data Entry Automation

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Your team re-types data from one system to another. We eliminate that.

inspection results test certificates non-conformance reports calibration records

Incoming Request Processing

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Requests come in from everywhere in every format. We read, classify, and route them.

customer complaints CAPA requests deviation reports supplier NCRs

Report & Dashboard Consolidation

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Your data lives in 5 systems. Getting one report means asking 3 people. We consolidate it.

quality KPIs CAPA aging reports defect trend analysis supplier quality metrics

Compliance & Audit Readiness

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Every audit is a fire drill. We keep you ready all the time.

ISO 9001/13485 FDA 21 CFR Part 11 IATF 16949 AS9100

Billing, Payments & Reconciliation

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Your finance team spends days matching payments to services. We do it in minutes.

warranty claims supplier chargebacks scrap cost tracking rework cost analysis

Risk Detection

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Problems hide in your data until they become expensive. We surface them early.

SPC anomalies complaint pattern detection supplier risk scoring recall prevention
See How We Work →
Case Studies Pricing

Common Questions About AI for Quality & Compliance

How does the AI handle our specific quality management system (QMS)?
We integrate with whatever QMS you run — whether it's a full platform like MasterControl, ETQ, or Veeva, or a combination of spreadsheets and SharePoint. The AI layer automates the data entry, routing, and documentation that happens around your QMS. We don't replace it — we eliminate the manual steps that slow down your quality team.
Can the AI maintain audit trails that satisfy FDA and ISO requirements?
Yes. Every action the AI takes is logged with timestamps, user attribution, and change history — full 21 CFR Part 11 compliance for FDA-regulated environments. For ISO 9001/13485, the AI maintains complete traceability from complaint receipt through CAPA closure. Auditors get clean, searchable records instead of paper trails.
How do you handle customer complaints that come in through multiple channels?
The AI monitors email, web forms, phone logs, and even customer portals. It classifies each complaint by product, severity, and type, then routes it to the right person with all context attached. No more complaints sitting in someone's inbox for a week. Your team investigates root causes instead of triaging and routing manually.
What if our quality processes are unique to our industry or product?
Every quality operation is unique. Our engineers spend the first 2 weeks inside your operation, learning your specific processes, terminology, and compliance requirements. The AI is configured for YOUR workflows, not a generic template. Whether you're making medical devices, automotive parts, or food products, we build for your reality.
How quickly can we see results from quality automation?
First workflow is live within 60 days. Most quality teams see immediate impact on CAPA cycle time and complaint response time. Typical results: CAPA closure time drops 40-60%, audit prep goes from weeks to days, and complaint routing goes from hours to minutes. We measure before and after on every engagement.
What's the total cost for year 1?
Two options. Per Workflow: $25K-$75K per workflow, best for starting with one high-impact process like CAPA tracking or complaint management. Dedicated Team: ~$22K/month for 2+ AI engineers embedded in your operation, building multiple workflows continuously. Most quality teams start with one workflow, prove the ROI, then expand. Every engagement starts with a free 30-minute assessment — no commitment.

Your quality team should investigate, not document.

Book a free 30-minute AI Assessment. We'll map your highest-volume workflows and show you the 3 processes with the highest ROI.

Book Your AI Assessment