The Problem

Medical device companies struggle with Excel-based traceability matrices. Manual updates lead to errors, version control issues, and audit nightmare scenarios. FDA 21 CFR Part 11 compliance requires electronic records with audit trails.

The Solution

A custom Quality Management System that automates the RTM (Requirements Traceability Matrix) linking design inputs to verification outputs.

• Automated LinkingRequirements automatically linked to test cases, design outputs, and risk controls.
• Audit TrailEvery change logged with user, timestamp, and reason—FDA Part 11 compliant.
• Real-time CoverageDashboard showing requirement coverage % and gaps before audits.