GxP Track℠ helps you meet 21 CFR Part 820 requirements without extra effort. Automate traceability, enforce procedures, and stay audit-ready. All from one modular platform.
21 CFR Part 820 - also known as the FDA's Quality System Regulation (QSR) - defines the quality management system requirements for medical device manufacturers. It covers every stage of the product lifecycle, from design to distribution. Key requirements include:
Validation of software & equipment
Device history & master record management
Corrective & preventive action (CAPA) tracking
Documented procedures for every critical process
Traceable records of design, production & quality events
Complying with Part 820 is essential to bring products to market, pass FDA inspections, and avoid costly enforcement actions.
Trying to manage 820 requirements with siloed tools or paper processes is a fast path to gaps and inspection findings. Without purpose-built software, it's difficult to:
Software like GxP Track℠ isn't just helpful in this kind of environment - it's critical.
We go way beyond document storage. GxP Track℠ gives you connected, auditable control over the entire device lifecycle. From SOPs and training to CAPA and design traceability.
GxP Track℠ captures every design iteration, change request, & approval with timestamped, user-tied records. You can document the full design history, assign review roles, & maintain clear traceability from initial concept through validation.
Version-controlled documents, approval workflows, & automated archiving ensure that only the latest approved versions are in use. GxP Track℠ maintains immutable audit trails for every edit, comment, & sign-off.
Track every process step - from operator input to machine data - with user identity, timestamps, & linked protocols. GxP Track℠ supports protocol-guided workflows & deviation tracking to ensure manufacturing stays within validated parameters.
Capture & store process validation data in structured, queryable logs. GxP Track℠ links validation activities to relevant SOPs, lots, & equipment, & allows you to prove control over critical processes with real-time audit trails.
GxP Track℠ provides a complete audit trail of inspections, including who performed them, when, what method was used.
Automatically log nonconformances & route them through configurable workflows for triage, resolution, or escalation. GxP Track℠ maintains full visibility of actions taken, links issues to related CAPAs or deviations, & prevents recurrence with enforced follow-up.
GxP Track℠ supports CAPA workflows that log root cause analysis, assign resolution steps, & verify effectiveness. All actions are recorded with timestamps & user identity, creating a tamper-proof audit trail for inspectors & internal reviews.
Ensure consistent, approved labeling by storing label templates & approval logs within GxP Track℠. Every update or revision is tracked, & current versions are always available to production - minimizing labeling errors & organizational data compliance risks.
All quality records - from design & process logs to training and audit data - are stored securely with full traceability. GxP Track℠ enables rapid retrieval, filtering, & export for inspections, making it easy to prove organizational data compliance on demand.
GxP Track℠ captures all complaint data in structured forms, links it to relevant product records, & assigns investigation steps with automatic tracking.
Book a demo to see how GxP Track℠ simplifies Part 820 organizational data compliance from design controls to device history - with audit-ready traceability at every stage.
See how GxP Track℠'s patented container architecture can streamline your quality management and reduce audit preparation time.