Beginning September 24, 2014 and going forward, all medical device manufacturers are required to meet the FDA mandated UDI compliance for their Class I, II and III devices, in phases.
The primary concern facing companies is how to navigate across some of the major challenges in the process of meeting the strict FDA timelines.
- Unidentified DI/ PI Sources & Data Configuration
- Inaccurate Document Version Control
- Error-prone Manual Data Submissions
- Non-existent Data Validation System
- Incompatible Publishing & Reporting
Effectively handling large volumes of unstructured data from disparate and non-authenticated sources is one of the biggest challenges for manufacturers in meeting their UDI compliance obligations. Add to that the lack of version control measures, cumbersome manual submission, and inadequate data management process making the challenges far greater to handle.
With the timelines getting shorter every day, companies are looking out for a right partner with an effective solution to successfully navigate through the UDI landscape. Freyr IDENTITY leverages the plan, process and training methodology to offer an end-to-end UDI compliance solution.
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 Expertise
- Data Management & Source Configuration: Freyr IDENTITY segregates relevant functions and specific data sources from within the company to connect and collate critical compliance data.
- Data Compilation: The collected source data is configured to the regulated submission format and thoroughly checked for redundancies, duplications, errors and omissions. The compiled data is maintained in a structured centralized database.
- Version Management: Freyr IDENTITY deploys an efficient Version-control system to ensure multiple rounds of data variations are captured and organized in indexed and searchable files.
- Data Validation: Freyr IDENTITY has an inbuilt Validator that uses FDA Algorithms and pre-validates the configured XML data with that of the FDA mandate. The accurate pre-validation ensures error-free submissions and cuts down on iterations.
- Data Submission: The validated XML data is published to FDA’s eSubmittal, the electronic submission gateway (ESG) via an automated submission process that meets the HL7 SPL protocols and receives the ACK 1/2/3 Reports.
- Publishing & Labels: The error-free, validated data can be generated into Reports with custom formats. The configured data along with the FDA approved format can be published to the print vendor for accurate Labels printing.
- Pre-built Training: Whether in a hosted environment or in the on-premises deployment, Freyr IDENTITY offers a comprehensive pre-built training to empower skills and enable compliance with GxP practice.
- Lifecycle Management: Right from deployment to training and regular maintenance, Freyr IDENTITY offers a complete solution to companies to easily manage multiple lifecycles of the updated, modified device information and frequent submissions.
Freyr IDENTITY Features
- Freyr IDENTITY can be configured to GS1, ICCBBA, HIBCC Issuing Agencies (IAs) to issue respective Device Information (DI) formats
- Streamlines data management and source configuration through expert planning
- Identifies the authenticated data source through the highly qualified Regulatory team
- Captures, Configures and manages all the critical 62 fields of Device Identifier (DI) attributes and 6 fields of Production Identifier (PI) attributes
- Efficient version control system to eliminate data redundancy and ensure accuracy
- Provides accurate data traceability and tracking across multiple lifecycles
- Powerful Validator to eliminate errors and edits at each stage of submissions
- Generates XML submissions in HL7 Complaint SPL protocol
- Generates multiple reports on validated data
- Publishes final data to label printer in FDA approved format
- Processes the data for label printing in accordance with the AIDC & HRI
Regulatory UDI Compliance CoE
With a fully configurable medical device data tracking and management software and with best-of-breed Regulatory professionals monitoring UDI compliance updates, Freyr offers companies the best of both worlds – on-demand UDI software solution as well as a Centre of Excellence that offers best in class, cost-effective and customizable UDI supporting services model built around clients’ unique and demanding requirements.
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