Innovit Releases Solution to Help Meet Regulatory Compliance
Innovit, a global master data management solution provider, is releasing the Unique Device Identification (UDI) Multi-Connector solutions, helping medical device manufacturers keep pace with regulatory compliance standards.
Innovit's UDI Multi-Connector helps global medical device manufacturers manage and automate the submission of UDI data using the HL7 SPL data format and messaging protocol required by the FDA and proposed by the EU Commission.
Innovit also stores a complete message exchange history, which provides organizations with full visibility and traceability of their data submission history.
For the FDA's GUDID (Global Unique Device Identification Database) requirements, Innovit's system is GAMP5 validated, and fully compliant with 21 CFR Part 11 requirements.
Organizations that have developed their own in-house UDI submission systems face the enormous cost of maintaining, upgrading, and validating these systems to GAMP5 standards.
The upcoming MDR requirements for Europe, which will require support for multi-lingual data, registration, and clinical documentation, will impose an enormous development and re-validation cost burden.
Innovit's UDI Multi-Connector allows global medical device suppliers to achieve compliance with UDI requirements while reducing operational, SQA, and other IT costs. This UDI solution is offered in conjunction with Innovit's PIM solution, and available through hybrid, public and private cloud hosting options.
For more information about this solution, visit www.innovit.com.