Does it support FDA 21 CFR Part 11?

Yes. Electronic signatures, audit trails, and access controls are built into the core — not add-ons. We deliver IQ/OQ documentation packages for regulated customers.

How does real-time ERP integration work?

We use event-driven adapters (RFC, IDoc, REST) that push production actuals to your ERP within seconds of floor events. Batch fallback ensures no data loss during ERP maintenance windows.

What about plants with poor network connectivity?

The MES runs locally on plant infrastructure with store-and-forward sync to the cloud. Operators never lose functionality during WAN outages.

Fixed-price build for the core platform plus per-plant licensing. Multi-plant rollouts get progressively lower per-plant costs.

Manufacturing / Manufacturing Execution System

Manufacturing Execution System

We engineer modern MES platforms that track every operation, material, and operator decision on the floor — giving production, quality, and planning teams a single, real-time picture of what's actually happening.

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18%

Average OEE improvement in first year

Real-time

Production visibility across all lines

100%

Part genealogy and traceability

Trusted by global innovators

Industry Overview

Manufacturing Execution System: Engineered End-to-End

Legacy MES platforms were designed for a world of static routings and long production runs. Today's mixed-model, high-changeover environments need an MES that adapts in real time — tracking production, enforcing quality gates, and feeding ERP with actuals, not estimates.

Industry Challenges

What Stops Most Teams From Solving This Today

Common friction points we hear from manufacturing teams scoping this kind of platform.

Paper-Based Tracking: Operators still log production counts, scrap, and downtime reasons on clipboards or whiteboards.
ERP Lag: SAP or Oracle get production data hours or days late — planning always works from yesterday's numbers.
Genealogy Gaps: Traceability breaks at manual steps, making recall scope broader and more expensive than it needs to be.
OEE Guesswork: Overall equipment effectiveness is calculated weekly in spreadsheets instead of measured continuously.

Our Approach

Our Engineering Approach

We engineer for the operational reality — not the demo.

Event-Driven Production Model

Every operation, scan, and sensor reading becomes an immutable event — traceability and analytics are built in, not bolted on.

Operator-First UX

Touchscreen interfaces designed for gloved hands, noisy floors, and operators who shouldn't need a training course.

Real-Time ERP Sync

Production actuals flow to SAP, Oracle, or your ERP within seconds — not overnight batches.

Capabilities

Production-grade features the platform ships with from day one.

Work Order Execution

Digital work orders with routing enforcement, operator instructions, and e-signatures.

Real-Time OEE

Availability, performance, and quality measured continuously per machine and line.

Part Genealogy

Full as-built records linking every component, operation, and test result to a serial number.

Quality Gates

In-process inspection enforcement with automatic hold and disposition workflows.

Downtime Tracking

Automatic downtime detection with operator-confirmed reason codes and Pareto analysis.

Material Consumption

Backflush and explicit consumption tracking with lot traceability.

Operator Dashboards

Line-side touchscreens showing targets, actuals, and quality alerts in real time.

ERP Integration

Bi-directional sync with SAP PP, Oracle Manufacturing, or Microsoft D365.

Reporting & Analytics

Shift reports, OEE trends, scrap Paretos, and custom KPIs.

How It Works

Reference Architecture

How data and decisions flow end-to-end.

Shop Floor Edge

PLC, barcode, and RFID data collected at line-side edge gateways.

Event Backbone

Kafka-based event stream captures every production event immutably.

MES Core Services

Work order, genealogy, quality, and material services with domain-driven design.

ERP Integration Layer

Real-time and batch adapters for SAP, Oracle, and other ERPs.

Operator Interfaces

React-based touchscreen UIs deployed on rugged line-side terminals.

Analytics & BI

OEE, downtime, and quality analytics fed to dashboards and BI tools.

Engineering Stack

Technology Stack

A pragmatic stack chosen for reliability, speed, and ease of operation.

Edge & OT

OPC-UAEtherNet/IPMQTTBarcode / RFID

Core

GoTypeScriptNode.jsGraphQLgRPC

Data

PostgreSQLKafkaTimescaleDBRedis

Apps

Next.jsReactTailwindPWA

ERP

SAP RFC/IDocOracle RESTD365 Dataverse

Infra

KubernetesVaultTerraformPrometheus

Measured Impact

Quantified outcomes from production deployments.

18%

OEE improvement

Average across discrete manufacturing deployments.

100%

Traceability coverage

Full genealogy from raw material to finished good.

90%

Faster ERP sync

From next-day batch to near-real-time actuals.

$2.1M

Annual scrap savings

Through in-process quality gates and SPC feedback.

Multi-Plant MES for a Medical Device Manufacturer

A medical device company running five plants on paper travelers and spreadsheet OEE needed a unified MES to satisfy FDA 21 CFR Part 11 and reduce time-to-release. We delivered a cloud-native MES in seven months.

Electronic batch records replaced paper across all lines, OEE improved 18% through real-time visibility, and lot release cycle time dropped from 14 days to 3 days with full audit trail.

Case Study

Multi-Plant MES for a Medical Device Manufacturer

Use Cases

Where This Earns Its Keep

Common deployment patterns we see across customers.

Discrete Assembly Tracking

Station-by-station execution with torque, test, and inspection data capture.

Batch Process Management

Electronic batch records with ingredient weighing and environmental monitoring.

Mixed-Model Lines

Dynamic routing and work instructions that adapt to the product variant at each station.

Changeover Management

Digital changeover checklists with time tracking and OEE impact analysis.

Rework & NCR Workflows

Non-conformance capture, disposition, and rework routing with full traceability.

Label & Packaging Control

Verified label printing with serialization and aggregation for track-and-trace.

Integrations

Integrates With Your Existing Stack

We connect to the systems your teams already know.

ERP

SAP S/4HANA PPOracle ManufacturingMicrosoft D365 SCM

SCADA

Rockwell FactoryTalk

PLC

Siemens TIA Portal

Labeling

Zebra Printers

QMS

ETQ Reliance

BI

Tableau / Power BI

Compliance-First Development Services Backed by Global Standards

We build secure, scalable products designed for privacy, interoperability, and regulatory readiness from day one across every sector we serve.

Service Organization Control 2

Verified controls for security, availability, and confidentiality of enterprise data systems.

Information Security Management

Adhering to the international gold standard for managing information security risks.

Quality Management Systems

Ensuring consistent quality in software delivery and operational process optimization.

Our Edge

Why Global Leaders Choose Us

We combine deep technical expertise with industry-specific knowledge to deliver solutions that aren't just functional, but transformational.

Enterprise-Grade Security

We implement rigorous security protocols and compliance standards (HIPAA, GDPR, SOC2) across all industrial solutions to protect sensitive data.

High-Performance Scaling

Our architectures are built to handle massive data loads and user bases, ensuring seamless performance whether you're serving ten or ten million.

Accelerated Time-to-Market

Leveraging our suite of internal tools and proven frameworks, we reduce development cycles and get your product to market 40% faster.

Embedded AI Integration

Beyond simple wrappers, we build deep-learning integrations and predictive analytics directly into the core of your industry-specific workflows.

Engagement Model

Predictable, structured delivery from kickoff through long-term ownership.

Discovery & Scoping

We map the existing systems, constraints, and stakeholders to scope a focused 8–12 week first delivery.

Architecture & Pilot

A working slice on a representative environment — proving the data flow end-to-end before scaling.

Production Engineering

Hardened services, observability, access controls, and audit logging go live behind your IAM.

Operate & Iterate

We stay on as the embedded engineering team — closing tickets, tuning models, and shipping new value.

Voices of Success

We don't just build products; we forge lasting partnerships. See how we've helped industry leaders transform their vision into technical reality.

"I can clearly see how Agnotic has a unique way of handling end-to-end development. They are always active on quick chat and provide support quickly."

Aaron Phelan

Founder, Benchmark

"Agnotic is the best technical team we evaluated. Their engineering excellence made our work dramatically easier and allowed us to stay focused on what matters most for maternal care outcomes. They took full ownership of the technical execution, and we are always happy to continue working together."

Kim Smith

Founder, My Lauren

"Agnotic combines deep technical expertise with strong domain knowledge. They understand the business context, anticipate challenges, and make collaboration smooth and effective."

John Pasmore

Founder, Latimer

The Same Engineering Patterns, Across Other Industries

The technical patterns behind this platform translate naturally into adjacent verticals.

Energy

Apply the same predictive analytics and IoT patterns to grid and renewable assets.

Transportation

Extend supply chain visibility into fleet, route, and last-mile orchestration.

Robotics

Pair smart factories with autonomous mobile vehicles and cobot fleets.

Frequently Asked Questions

Yes. We run parallel with your existing system line-by-line, migrating one area at a time. Production never stops — operators switch over during planned changeovers.