Pharmaceutical and Medical Device Authentication
In-Sight Track & Trace
A complete identification and data verification solution for healthcare serialization
- Reads 2-D and 1-D barcodes: Data Matrix, GS1-128, GS1 DataBar, securPharm and Pharmacode
- Verifies correct ID code contents, including compliance with the GS1 Healthcare data standard
- Conforms to 21 CFR Part 830 GS1 validation for Unique Device Identification
- Supports FDA 21 CFR Part 11 validation compliance with change tracking, double blind and secondary authentication
- Provides Data Matrix Mark Quality Assessment during production to detect changes in print quality
- Verifies the accuracy of printed text
- Detects label misalignment and skew
- Supports bundle aggregation
Conforms to 21 CFR Part 830 GS1 Validation for UDI
Track & Trace validates plain text to GS1 linear and Data Matrix codes meeting the FDA’s Unique Device Identification label requirements for 21 CFR Part 830. With Cognex Track & Trace validation documentation, In-Sight Track & Trace easily integrates to any serialization packaging line.
NEW: Track & Trace Validation Documentation for Cost Effective Easy IntegrationBased on the GAMP5 guidelines for validation of In-Sight Track & Trace as an automated system in pharmaceutical and medical device packaging, this documentation includes all components required to validate Track & Trace as a Category 4 system:
- The Functional Specification and Hardware & Software Design Specification (FSDS)
- The Installation Qualification & Operational Qualification documentation for validating the installation and operation of Track & Trace in accordance with FSDS documentation
- The Traceability Matrix to ensure all requirements have been implemented and tested prior to deployment
Easy to Integrate, Easy to Use
A touch screen friendly user interface makes Track & Trace easy to configure and operate. You can integrate the Track & Trace interface into a PC-based HMI or custom application or for a ready-to-deploy solution, Track & Trace can also be controlled using the Cognex VisionView operator interface panel or VisionView PC software.
Ready for 21 CFR Part 11 Validation?
Track & Trace provides the technical controls needed for FDA 21 CFR Part 11 validation, including secure user authentication and support for automatic audit trail generation. Plus, the compact, all-in-one In-Sight “smart camera” systems are easier for you to maintain and validate for Part 11 compliance than most Windows® PC-based vision systems.