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
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.
Technologies & Services Used
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