# Epicor Kinetic AI for Medical Device Manufacturers: Traceability, CAPA and DHR Questions, Read-Only

> Source: https://netray.co/erp-ai/epicor-kinetic-medical-device-ai
> Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems.
> Section: AI for ERP

## Short answer

AI for Epicor Kinetic in a medical device company gives quality, regulatory and operations staff a read-only way to ask about lot and serial traceability, nonconformances, CAPA status, supplier history and device history record contents in plain English, with sources cited. It runs on-prem or in a private cloud, sits outside the validated quality record, and leaves compliance decisions with your quality system.

## Kind

industry

## Erp Family

epicor

## Erp Products

- Epicor Kinetic

## Industries

- Medical Devices
- Life Sciences
- Contract Manufacturing

## Region

Global

## Persona

Quality Manager

## Eyebrow

Kinetic + medical devices

## Intro

A device manufacturer lives with a simple, unforgiving requirement: reconstruct what happened to any unit, on demand. Under FDA 21 CFR Part 820 (the Quality Management System Regulation, which incorporates ISO 13485:2016) and the EU MDR, that means device history records, lot and serial genealogy, supplier controls, and corrective action evidence that can be produced for an auditor or a field action without a scramble.

Kinetic holds much of the raw material for that: part revisions, lot and serial tracking, job and operation records, nonconformance and inspection data, supplier purchase history. In many companies the rest sits in an eQMS, document control system, or shared drives. The questions that matter, such as which shipped units contain components from a supplier lot now under investigation, cross all of these.

A language layer can shorten the search, but in this industry restraint is the whole point. It must be read-only, cite what it used, avoid making quality decisions, and stay outside the validated records. A tool that quietly writes to a design or production record would create more compliance problems than it solves.

This page lays out how to use AI over Kinetic in a way a quality unit can accept, with scope limits stated, and where it genuinely helps with traceability, CAPA triage and audit preparation.

## Pain Points

### Traceability queries take too long

**Detail:** A supplier lot nonconformance requires tracing forward to finished goods, shipments and customers. Doing so across lots, jobs and shipments by hand can take days when speed matters.

### DHR assembly is document-heavy

**Detail:** Compiling a device history record means collecting routings, inspection results, labels and sign-offs from several systems, and gaps are found late.

### CAPA data is hard to see in aggregate

**Detail:** Recurring causes across nonconformances and complaints are visible only when someone reads many records and categorizes them.

### Supplier file review is manual

**Detail:** Approved supplier status, audit dates, incoming inspection history and certificates live in different places, so periodic supplier evaluation is a paperwork exercise.

### Audit preparation pulls skilled people off their jobs

**Detail:** Auditor requests for samples of records interrupt the quality team for days, since the search tools are not built for sampling questions.

## Use Cases

### Forward and backward lot genealogy

**Description:** Quality asks which finished lots and customers received product made with a given component lot, or the reverse, and gets a traced list with sources.

**Erp Objects:** Erp.PartLot, Erp.LotSelectedTracking, Erp.JobMtl, Erp.JobProd, Erp.ShipDtl, Erp.SerialNo

**Outcome:** A fast first-pass trace that quality verifies; useful for field action scoping and mock recalls.

### UDI and label attribute lookup

**Description:** Regulatory asks which products carry which device identifiers and production identifiers, and whether the data in Kinetic matches labeling records.

**Erp Objects:** Erp.Part, Erp.PartRev, Erp.PartLot, UD fields for UDI, label records

**Outcome:** Quicker consistency checks ahead of GUDID updates or audits; submissions remain a regulatory task.

### Nonconformance and CAPA trend triage

**Description:** Quality asks for recurring failure causes by part, supplier, line or period across nonconformance records, with records linked.

**Erp Objects:** Erp.NonConf, Erp.DMRHead, Erp.Part, Erp.Vendor, quality or CAPA records

**Outcome:** A starting point for CAPA prioritization, which a person confirms.

### DHR completeness check

**Description:** Before release, the assistant lists which expected records, such as inspections, operation sign-offs and label entries, are present or missing for a lot.

**Erp Objects:** Erp.JobHead, Erp.JobOper, Erp.LaborDtl, Erp.InspResults, attached records

**Outcome:** Fewer late-found gaps; release authority stays with the quality unit.

### Supplier performance summary

**Description:** Purchasing and quality ask for a supplier's receipt, rejection and delivery history with certificates and audit dates attached.

**Erp Objects:** Erp.Vendor, Erp.RcvHead, Erp.RcvDtl, Erp.NonConf, Erp.PODetail

**Outcome:** Less preparation time for periodic supplier evaluation.

### Audit sample retrieval

**Description:** During an audit, staff ask for records matching an auditor's sampling request, such as ten lots of a device shipped in a quarter, and get the set with sources.

**Erp Objects:** Erp.PartLot, Erp.JobHead, Erp.ShipHead, Erp.NonConf

**Outcome:** Shorter audit interruptions, with every returned record traceable to its source.

### Procedure and work instruction Q&A

**Description:** Operators and engineers ask questions of controlled SOPs and work instructions and get the answer with the document number and effective revision.

**Erp Objects:** Document control system or file share, Erp.PartRev for linked instructions

**Outcome:** Faster procedural lookups; the controlled document is always the cited source.

## Architecture

**Overview:** The assistant is a read-only retrieval and query layer outside the validated Kinetic and eQMS records. It queries through REST or a read replica, cites every record, and cannot create or modify quality data. Model, prompts and query templates are versioned and under change control.

**Layers:**

#### Read-only Kinetic access

**Detail:** A dedicated least-privilege service account with REST and curated BAQs for lots, serials, jobs, nonconformances and shipments.

#### Genealogy query library

**Detail:** Forward and backward trace implemented as fixed, tested, version-controlled queries so the model does not improvise regulated logic.

#### Controlled-document retrieval

**Detail:** SOPs, work instructions and certificates indexed with document number and effective revision, excluding superseded versions by default.

#### Private inference

**Detail:** Open-weight models served with vLLM or Ollama on your hardware or sovereign cloud, with pinned model versions.

#### Audit trail

**Detail:** Immutable log of questions, queries, results and users, retained per your records policy.

## Deployment Options

### On-prem validated-adjacent

**Fit:** Manufacturers with strict quality-system boundaries

**Detail:** AI server in a controlled network segment, with read-only credentials and documented change control.

### Private cloud tenant

**Fit:** Companies already running regulated workloads in a cloud subscription

**Detail:** Model endpoint in your tenant with private networking to Kinetic and a logging policy that matches your records retention.

### Document-only pilot

**Fit:** Teams starting with SOP and supplier document search

**Detail:** No ERP access initially; adds Kinetic traceability queries after the quality unit approves scope.

## Compliance

### Position the assistant as a search aid outside the quality record; document its intended use, limits and change control within your quality system.

**Framework:** FDA 21 CFR Part 820 (QMSR) and ISO 13485:2016

### Because it is read-only and creates no regulated records, risk is lower, but your team decides the assurance level; we supply test evidence and logs.

**Framework:** 21 CFR Part 11 and computer software assurance

### UDI-related fields are read for consistency checks; submissions and labeling decisions stay with regulatory staff.

**Framework:** EU MDR and UDI (21 CFR 830)

### Private inference and role restrictions keep any patient-related complaint data off public services; scope PHI handling with your privacy officer.

**Framework:** HIPAA where PHI could appear (complaints)

### Supplier files are summarized from your own records with citations; approval decisions remain with quality.

**Framework:** Supplier controls under ISO 13485 clause 7.4

## Integration Notes

- Confirm where CAPA and complaints live; if an eQMS holds them, add a read connector rather than copying data into Kinetic.
- Test genealogy queries against a mock recall with a known answer before anyone relies on them.
- Exclude superseded SOP revisions from retrieval by default and show the effective date in every answer.
- Pin the model and prompt versions and record them in your change control.
- Use a service account with no write permissions in Kinetic, verified in the security group settings.
- Store UDI data fields consistently; the assistant flags mismatches but never corrects them.

## Product Fit

### ERPray

**Why:** Read-only, role-aware questions over Kinetic lots, serials, jobs and nonconformances, with queries visible for review.

### DataRay

**Why:** Controlled-document and supplier-file retrieval across file shares and an eQMS.

### Custom build

**Why:** When CAPA, complaint and eQMS data must be joined to Kinetic genealogy under your change control.

## Engagement

### Scope and risk assessment

**Duration:** 2 weeks

**Deliverables:**

- Intended use statement and out-of-scope list
- Risk assessment agreed with quality
- Data source and permission map

### Build and verify

**Duration:** 3-5 weeks

**Deliverables:**

- Tested genealogy query library
- Document index with revision handling
- Verification evidence and test log

### Controlled pilot

**Duration:** 4 weeks

**Deliverables:**

- Mock recall and audit sampling exercises
- Accuracy results reviewed by quality
- Change control entries

### Operate

**Duration:** Ongoing

**Deliverables:**

- Periodic accuracy review
- Model and prompt change control
- Runbook and retention policy

## Buyer Questions

- Is the assistant strictly read-only, and can you show the permissions?
- How is the traceability logic tested, and by whom?
- How are model and prompt changes controlled?
- Does it exclude superseded document revisions?
- What is the documented intended use and limit of reliance?
- Where are logs stored and for how long?
- Could any complaint or PHI data leave our network?
- What happens if it returns an incomplete trace?

## Faq

### Does this need to be validated like Kinetic?

**Answer:** That is your quality unit's call. Because the assistant is read-only and creates no regulated records, many teams treat it as a lower-risk search aid and apply a proportionate, risk-based assurance approach. We provide test evidence, versioning and logs to support that decision, but we do not make it for you.

### Can it replace our recall procedure?

**Answer:** No. It can speed up the first pass of tracing forward and backward through lots and shipments, but recall decisions and regulatory reporting follow your documented procedures. Any trace used in a field action should be verified against source records.

### How does it handle superseded SOP revisions?

**Answer:** Retrieval defaults to the current effective revision and shows the document number and date with each answer. Superseded versions can be searched deliberately, for example for historical investigations, but are labeled so no one mistakes them for current instructions.

### Is patient information at risk?

**Answer:** Complaint records can contain health information. Private inference and role-based access keep that data inside your environment, and you can exclude complaint sources entirely. Scope this with your privacy officer before indexing anything of that kind.

### Will it write CAPA records for us?

**Answer:** Not by default. It can summarize trends and draft text for a person to review, but creating or changing quality records stays manual or inside your validated eQMS workflow. This keeps the assistant outside the regulated record and simplifies assurance.

### Does it work if CAPA lives in a separate eQMS?

**Answer:** Yes, through a read connector or export keyed by nonconformance, part or lot number. The assistant then joins Kinetic genealogy to CAPA records. Without a connector it answers from Kinetic nonconformance data only and says what it cannot see.

### What model risk should we document?

**Answer:** Document intended use, known limitations such as incomplete data or ambiguous questions, the pinned model version, the test set and results, and the human review step. Treat model updates as controlled changes, re-running the test set before release.

## Search terms

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