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 manufacturers 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.
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.
Automate comprehensive record collection with electronic signatures while maintaining 21 CFR Part 11 and Part 820 compliance.
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.
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.
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 and an integrated scripting environment allow the construction of 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.