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.

Reduce Compliance Risk

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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.

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TrakSYS-Powered Compliance

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TrakSYS-Powered Compliance

Regulatory pressure doesn't ease up, and neither should your traceability. See how TrakSYS gives manufacturers the audit-ready records, electronic signatures, and closed-loop controls needed to meet FDA, GMP, and ISO requirements without slowing down the line.

What is inside

Electronic batch records and e-signatures built for 21 CFR Part 11 and Part 820

Real-time non-conformance alerts with root-cause context

Configurable audit trails across users, actions, and system changes

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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.

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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.

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