Compliance Solution Overview

Regulatory compliance is non-negotiable in industries like pharmaceuticals, medical devices, food and beverage, and other highly regulated environments. In this Compliance Solution Overview, we show how TrakSYS simplifies the complexity of maintaining global compliance standards—from FDA and GMP requirements to ISO frameworks and European regulations.

TrakSYS provides a unified digital platform that enforces validated workflows, automates data capture, and ensures every action in the production process is traceable, contextualized, and auditable. Instead of relying on paper forms, manual checks, or disconnected systems, TrakSYS brings discipline and consistency to compliance management.

With TrakSYS, manufacturers can:

• meet regulatory standards such as 21 CFR Part 11, Part 820, GMP, ISO 9001, ISO 13485, and European Annex 11
• enforce user-defined rules and validated workflows
• automate data collection across the full value stream
• receive real-time notifications of nonconformances or deviations
• assign responsibilities with detailed, contextualized corrective actions
• maintain complete genealogy of materials, processes, and decisions
• leverage accurate, timely data to respond to production variances
• generate secure, electronic records for audits and internal review

TrakSYS supports full lifecycle compliance—from preventing issues on the shop floor to maintaining records that withstand regulatory scrutiny. With digital signatures, comprehensive audit trails, and end-to-end traceability, the platform provides confidence and clarity across operations.

TrakSYS — empowering your digital transformation through simpler, smarter regulatory compliance.