From Factory Floor to FDA Cloud: Real-Time Manufacturing Traceability

By LMD engineering team -This article has been published on our LinkedIn page.

Objective: Show how real-time, cloud-backed traceability turns manufacturing data into regulatory leverage for postmarket surveillance, recalls, and continuous improvement.

The Problem

Many device makers still treat manufacturing records as static archives. That’s risky. FDA requires robust Device History Records (DHRs) and supports a Unique Device Identification (UDI) system to tie produced units to components and processes. When issues arise, the clock starts on Medical Device Reporting (MDR) timelines and, in some cases, Section 522 postmarket surveillance obligations. Without granular, trustworthy data, recall scope balloons and patient risk rises.

Auditability matters, too. 21 CFR Part 11 requires secure, time-stamped audit trails for electronic records that “do not obscure previously recorded information”—and those trails must be retained and ready for FDA review. Paper processes and unmanaged spreadsheets don’t meet that bar in 2025.

The IoT + Serverless Solution (AWS)

Instrument production lines and route telemetry into a validated, Part 11-aligned data repository:

• Edge to Cloud: Connect sensors, testers, and travelers via AWS IoT Core. Use the Rules Engine to route MQTT events to Lambda, DynamoDB, S3, or Kinesis for streaming analytics and durable storage.

• Lineage & Immutability: Store manufacturing events and genealogies in append-only log structures. Protect them with S3 Object Lock (WORM) and retention policies to prevent tampering and to preserve evidence for regulators.

• Real-time IDs: Assign and validate UDI metadata at pack-out; bind serials to component lots, stations, and test results so that later, a specific lot or time window can be isolated in minutes, not days.

• Surveillance & MDR Support: Build dashboards and alerts tuned to MDR thresholds and Postmarket Surveillance (Part 822) plans, so emerging patterns trigger investigation before adverse events accumulate.

The LMDlogic.com Angle

LMDlogic GlobalSight (for operations data) plus ATS (for evidence and integration) provide a validated repository pattern with:

• CFR Part 11 controls: Electronic records with time-stamped audit trails, role-based access, and retention aligned with your quality procedures.

• Traceability apps: Prebuilt connectors for station data, lot tracking, and test attachments, tied to UDI and serial numbers.

Practical Example: A Rapid, Targeted Recall

An implant manufacturer discovers that a torque driver used for a single week on Line B was out of calibration. Because every assembly event published to IoT Core captured the driver’s ID, station, operator, serial, and torque result, the quality team queries GlobalSight to identify exactly which serials were affected—units 3,412 through 3,598, all with UDI batch code XJ-17. The team issues a targeted field correction and files MDRs where required, supported by immutable evidence: device genealogy, test results, and the calibration record.

With QMSR coming into force in 2026, building this data discipline now means your inspection story aligns with ISO 13485-style expectations—and your field actions are surgically precise rather than sweeping.