21 CFR Part 11 Compliant.
Unique Device Identification (UDI) promises to improve patient safety and traceability by establishing processes to adequately identify medical devices through their distribution and use. However, this presents a major challenge for manufacturers that lack the ability to effectively centralize and manage product data required by regulatory agencies. It is even more challenging for global manufacturers that need to submit UDI data to a myriad of country-specific regulatory agencies, each with their own unique requirements.
Innovit’s UDI Compliance solution solves these challenges by allowing device manufacturers to implement a single “global system and unified process” to aggregate, validate and submit product data to country specific regulatory agencies. Innovit’s UDI solution is also GAMP validated and 21 CFR Part 11 compliant to meet the unique validation requirements of the healthcare and medical device industry. ◼