Medical Devices

FDA-Compliant Manufacturing with Full Traceability

How a medical device manufacturer achieved 100% lot traceability and reduced compliance overhead by 40% with Rootstock ERP.

100%

Lot Traceability

40%

Reduction in Compliance Overhead

90%

Faster Audit Preparation

Zero

FDA Findings on System Controls

Client

Medical Device Manufacturer

Industry

Medical Devices

Employees

150+

Platform

Rootstock

The Challenge

As a manufacturer of Class II medical devices, the company faced strict FDA requirements for traceability and documentation. Their legacy systems couldn't provide the audit trail needed for compliance.

✗FDA 21 CFR Part 11 compliance requirements with manual documentation
✗No lot traceability from raw materials through finished goods
✗Quality events tracked in spreadsheets with no visibility
✗Audit preparation took weeks of manual document gathering
✗Production records disconnected from quality management

The Solution

We implemented Rootstock ERP with a focus on FDA compliance, building custom quality management workflows that integrated seamlessly with manufacturing operations.

Rootstock ERP with full lot and serial tracking enabled
Custom quality management workflows for NCRs and CAPAs
Electronic signatures and audit trails for FDA compliance
Integrated supplier quality management and incoming inspection
Automated device history record (DHR) generation

The Results

Within six months of go-live, the company achieved complete lot traceability from incoming raw materials through finished device shipment. Every component, every process step, and every quality event is now documented automatically.

When the FDA conducted their next audit, preparation that previously took three weeks was completed in two days. The auditors were able to trace any lot number through the entire production history with a few clicks.

The quality team now spends their time on process improvement rather than paperwork. Non-conformances are tracked, CAPAs are managed, and trends are visible in real-time dashboards.

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UniqueIT

The Challenge

✗FDA 21 CFR Part 11 compliance requirements with manual documentation

✗No lot traceability from raw materials through finished goods

✗Quality events tracked in spreadsheets with no visibility

✗Audit preparation took weeks of manual document gathering

✗Production records disconnected from quality management

The Solution

We implemented Rootstock ERP with a focus on FDA compliance, building custom quality management workflows that integrated seamlessly with manufacturing operations.

Rootstock ERP with full lot and serial tracking enabled

Custom quality management workflows for NCRs and CAPAs

Electronic signatures and audit trails for FDA compliance

Integrated supplier quality management and incoming inspection

Automated device history record (DHR) generation

The Results

The quality team now spends their time on process improvement rather than paperwork. Non-conformances are tracked, CAPAs are managed, and trends are visible in real-time dashboards.