GAMP 5 validated ~ 21 CFR Part 11 compliant.
Global device manufacturers must often submit UDI data to a myriad of country-specific regulatory authorities, each with their unique data exchange standards and requirements. Innovit’s UDI compliance solutions enable device manufacturers to implement a single data syndication system for global coverage. Leveraging one solution to aggregate, validate and submit product data to regulatory agencies at the market-specific level around the globe.
FDA-approved for GUDID submissions. GAMP 5 validated and 21 CFR Part 11 compliant ~ it’s tailored to meet the unique system validation requirements (SQA) of medical device and healthcare industries.
EUDAMED and China UDID testing ‘playgrounds’ coming soon!
Features & Benefits
Dedicated Customer Success Specialist
Vamshi is well known for building and sustaining strong client relationships. He leverages his diverse experience in Business Analytics and Quality Assurance to help all Innovit customers achieve success.
When Vamshi isn’t chasing after his five children, you will find him enjoying a good book.