Built for Trust. Certified for Enterprise.
Globally Recognized. Enterprise-Ready.
TrakSYS unifies data, systems, and teams to eliminate silos and bring clarity to complexity. With modular architecture, real-time insights, and enterprise-grade flexibility, it’s designed to meet you where you are—and help you grow.
ISO/IEC 27001:2022
Certified Information Security Management System (ISMS) ensuring confidentiality, integrity, and availability of your data.
ISO 9001:2015
Certified Quality Management System (QMS) demonstrating our commitment to consistent, high-quality processes and customer satisfaction.
GxP & GMP Alignment
Supports compliance with Good Manufacturing Practices and FDA regulations through audit-ready digital records and traceability.
21 CFR Part 11 Support
Electronic signatures, secure audit trails, and access control to meet regulatory needs.
Proven Security from Infrastructure to Application
From system architecture to deployment best practices, TrakSYS is engineered for resilience and security at scale.
Trusted by the World’s Most Regulated Manufacturers
"TrakSYS enabled electronic batch records, real-time data visibility, and GMP/21 CFR Part 11 compliance. The platform connected disparate systems, reduced paper usage by 100,000 sheets annually, improved data integrity, and supported continuous improvement across the enterprise—all while enhancing productivity, reducing defects, and streamlining changeovers."
Juan G.
Chief Information Officer | Mid-Market (51-1000 emp.)