streamline compliance.
improve quality.


Today’s regulatory environment demands better quality and compliance processes. Is your existing system efficient and effective? Can it handle new requirements from FDA and other regulators? TrakSYS enables compliance with the FDA’s 21 CFR Part 11 and European Annex 11 regulations for electronic records.

TrakSYS automates your recordkeeping process and stores all necessary documents in a centralized, web-based location so every stakeholder involved in your process can find the most up-to-date documents in one place. All configuration changes, actions, recorded value adjustments, and electronic signatures are recorded for the creation of a comprehensive audit trail. Interactive reports and dashboards allow filtered queries of the audit trail.

  • Automate Collection of your process data from raw materials to finished product
  • Combine data collection with your operator observations, workflow checks, and feedback
  • Real-time notifications of non-conformance events
  • Accurate production information to meet your regulatory reporting requirements
  • Compliance and traceability throughout production processes built in by design

TrakSYS makes it possible to easily define the rules for data capture from various sources needed for real-time and historical analysis of process behavior and regulatory reporting. The availability of contextualized information provides deeper insight into the causes of poor quality and the needed corrective actions.

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Success Story
regulatory compliance

Eckes-Granini wanted to maintain accurate electronic production records and keep track of critical process values, to comply with food safety regulations. They chose TrakSYS as a complete electronic document system, and enjoyed the added benefit of reducing overfill by 30% and increasing production performance by 10%.