Streamline Compliance, Enhance Quality, and Protect Your Brand
In today’s stringent regulatory environment, maintaining compliance is not just about avoiding penalties—it’s about safeguarding your brand and ensuring product quality. TrakSYS provides a unified platform to automate record-keeping, enforce standard operating procedures, and maintain audit-ready documentation, helping you meet regulatory requirements efficiently.
Take Control of Complex Regulatory Requirements
Industries regulated by bodies like the FDA and EU face evolving compliance challenges. TrakSYS helps you:
Automate data collection and record-keeping processes.
Maintain compliance with standards such as FDA 21 CFR Part 11, Part 820, GMP, ISO 13485, European Annex 11, and ISO 9001.
Ensure traceability of materials and processes.
Reduce administrative costs and improve efficiency.
TrakSYS enables you to digitize our compliance processes, reduce errors and ensure readiness for any audit.
Comprehensive Compliance Management Features
Electronic Records & Signatures
Automate comprehensive record collection with electronic signatures to maintain compliance with regulations like 21 CFR Part 11 and Part 820.
Audit Trail
Configure user and group roles to maintain data integrity, and track changes to system configurations, actions, and data records for a comprehensive audit trail.
Change Management
Implement controls to manage system changes effectively, mitigating risks associated with unapproved modifications.
Traceability
Record, track, and trace the genealogy of raw materials, work-in-process, and finished products to ensure full transparency and quick response to quality issues.
Visual Workflow
Design, manage, and execute compliant processes using visual workflows that standardize operations and reduce variability.
Real-Time Monitoring
Receive real-time notifications of non-conformances, enabling immediate corrective actions and continuous improvement.
Real-World Results: Strengthening Compliance and Operational Control
Discover how Bush Brothers used TrakSYS to replace paper-based processes, improve regulatory compliance, digitize records, and maintain audit readiness across their operation—all while increasing efficiency and reducing variability.
TrakSYS for Proactive Compliance Management
TrakSYS offers a scalable, configurable platform that adapts to your compliance needs, ensuring you stay ahead of regulatory changes and maintain product quality.