precise, efficient, swifter
UDI compliance solution
Handling huge volumes of unstructured information from disparate and non-authenticated sources is one of the most significant challenges for manufacturers in acquiring their UDI compliance obligations. Additionally, the lack of version control measures, clumsy manual submission, and insufficient data management procedure makes the tasks difficult to manage.
With the timelines becoming shorter every day, enterprises are looking for a partner with an efficient solution to navigate the UDI landscape productively. Freyr IDENTITY offers the plan, process and training approach to extend an end-to-end UDI compliance solution.
Freyr IDENTITY guarantees reliable Regulatory compliance with GxP practice 21 CFR Part 11, comprising additional compliance capabilities like version control, validation, XML conversion based on SPL and HL7 protocols, and publishing and printing to allow precise, efficient, and quicker UDI compliance.
data management & source configuration
pre-built training & lifecycle management
publishing & labels
data validation & data submission
configured to GS1, ICCBBA, HIBCC issuing agencies (IAs) to issue respective device information (DI) formats
streamlines data management and source configuration through expert planning
efficient version control system to eliminate data redundancy and ensure accuracy
generates XML submissions in HL7 complaint SPL protocol & multiple reports on validated data
powerful validator to eliminate errors and edits at each stage of submissions
provides accurate data traceability and tracking across multiple lifecycles