Freyr launches Freyr IDENTITY, the accurate, efficient and faster UDI compliance solution. Freyr IDENTITY is the latest addition to Freyr’s growing Regulatory Software Solutions portfolio and is aimed at enabling medical device companies successfully navigate through the UDI compliance landscape.
Suitable for a company of any size with any number of devices, Freyr IDENTITY is exclusively designed to streamline the complete compliance process by connecting disparate internal functions and integrating data sources and formatted information with a centralized database for automated XML generation and submission that meets all the FDA regulated UDI mandates.
Freyr IDENTITY ensures reliable regulatory compliance with GxP practice, 21 CFR Part 11 including additional compliance capabilities like Version control, Validation, XML Conversion based on SPL and HL7 protocols, as well as Publishing and Printing to enable accurate, efficient and faster UDI compliance.
Freyr IDENTITY is differentiated with its advance architecture and unique features.
- In-built Version Control and advanced Validation as per FDA Algorithm
- Captures, configures and manages all the critical 62 fields of Device Identifier (DI) attributes and 6 fields of the Production Identifier (PI) attributes
- Auto XML Generation and GUDID Submissions compliant with HL7 & SPL
- Data configured to GS1, ICCBBA, HIBCC Issuing Agencies (IAs) Formats
- Processes validated data for label printing in accordance with AIDC & HRI
- Accurate Data Traceability and Tracking across multiple Lifecycles
Freyr IDENTITY takes up all the inherent challenges of medical device manufacturers and provides an effective and streamlined solution to meet the complex UDI Compliance requirements efficiently.