streamline compliance.
improve quality.


Today’s regulatory environment demands better quality and compliance processes. For those in industries regulated by the FDA and EU compliance, it is crucial to have systems that assure stringent compliance with government and industry standards — as well as extensibility to comply with future requirements. TrakSYS is a unified Manufacturing Operations Management (MOM) platform that helps manufacturer’s meet an assortment of regulatory requirements and standards including FDA’s 21 CFR Part 11, Part 820, GMP, ISO 13485, European Annex 11, and ISO 9001.

Comply with Regulatory Requirements

Protect Customer Safety and Brand Reputation

Efficiency and

Minimize Administration Costs

TrakSYS makes it possible to easily define the rules of automating your data collection throughout the production process. With digital record-keeping, ensuring Traceability and Compliance are built-in by design. All necessary documents are easily accessible to authorized users through a web interface. Interactive reports and dashboards provide real-time notification of non-conformance, contextualized information for identifying root causes, and comprehensive audit trail.


Record, track, and trace the genealogy of raw materials, Work-in-Process (WIP), and go-to-market products. Provide real-time transparency, to help you proactively limit the impact of any quality problems before you ship the product.

21 CFR Compliance – Digital Signature

Automate comprehensive record collection with electronic signatures while maintaining 21 CFR Part 11 and Part 820 compliance.

Change Management

Managing change is a critical element of a risk mitigation strategy. A failure to manage change is a risk in and of itself that commonly traces back to major crises. TrakSYS ensures controls are in place to introduce system changes as well as maintain data integrity.

Audit Trail

TrakSYS allows configuration of user and group roles to maintain data integrity. As well as a configurable tracking of changes to system configuration, actions, data records, and electronic signatures to create a comprehensive audit trail.

Development – Test – Production Environments

TrakSYS architecture allows for parallel environments to manage FDA validated software installations. Develop without interruption, while system changes are tested and validated for production activation.


Web-based configuration tools allow you to build tailored solutions without the need for custom code.


TrakSYS is a full MOM platform, with standard function libraries that can be readily adjusted to create focused solutions in a fraction of the time compared to traditional development. This important functionality delivers both rapid deployment and cost-effective extensibility.

Learn More About Compliance

Want to learn more about Compliance? Check out these handy documents.

White Paper

Quality Takes
the Lead

Many manufacturers are looking to proactive, real-time quality management processes and software applications to facilitate continuous improvement across these areas.


TrakSYS Next-Generation MOM platform

TrakSYS has been designed to work the way you work: fast, flexible, and focused on solving specific business challenges.

Case Study

Complexities in Compliance made simple with Modular MES

To excel in the highly competitive medical device industry, Proteus needed a software solution that could unify their production workflows and unique processes.

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