Product News: Software
UDI Compliance Software targets medical device companies.
Press Release Summary:
July 16, 2014 - Suitable for companies with any number of devices, Freyr IDENTITY streamlines compliance process by connecting disparate internal functions and integrating data sources and formatted information with centralized database for automated XML generation and submission that meets FDA regulated UDI mandates. Software ensures compliance with GxP practice, 21 CFR Part 11 including additional compliance capabilities like Version control, Validation, and XML Conversion based on SPL and HL7 protocols.
Original Press Release
Freyr Launches Freyr IDENTITY: The Accurate, Efficient and Faster UDI Compliance Solution
Press release date: July 14, 2014
New Jersey, US — 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.
Freyr IDENTITY is available at Freyr’s corporate website. Visit www.freyrsolutions.com for more details.
About Freyr Solutions
Freyr is a fast-growing, Global Regulatory Solutions and Services company, exclusively focusing on the entire Regulatory value-chain of Life Sciences companies.
Freyr offers Consulting, Software & Operations Outsourcing Services of Regulatory Affairs, Operations & Information Management functions to Large & Small-Medium Life Sciences companies. Freyr specializes in offering high-value Regulatory Solutions & Services in a highly cost-effective model.
Freyr supports Fortune companies through large, centralized, Regulatory Outsourcing Programs to undertake end-to-end, Global Regulatory responsibility in a low-cost, offshore/onsite model, enabling significant savings in cost of compliance & regulatory functions.
For more information please visit our web site http://freyrsolutions.com
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