PTC Unique Device Identification Solution

The PTC UDI Solution:
  • Communicates and Tracks UDI requirements, providing automatic data formatting and submission, FDA response monitoring for quick correction, and enterprise-wide compliance reporting

  • Governs the UDI submission process by supporting 21 CFR Parts 11 and 820 with secure electronic records, technology validation, and fully documented training, all within a scalable software architecture to meet emerging global UDI requirements

  • Manage and Synchronize changes to keep UDI submissions current with product updates, offering capabilities to collect and control UDI data from across the organization with OOTB templates, preconfigured workflows, and change/configuration management

The PTC UDI solution combines OOTB technology, services, and training to offer an end-to-end solution for managing UDI submissions.