A global medical device manufacturer and leader in new product development and medical education in orthopedics, this company needed a PIM software solution with GDSN connector to comply with the FDA Unique Device Identification (UDI) regulation.

Challenge

As a medical device company, this firm was subject to a new FDA UDI regulation and needed to submit standardized product data to the US federal government by a certain deadline in the near future. A subset of this company’s thousands of products were subject to regulation, and these needed to be enriched with the right data and approved for submission to the FDA. The process and system being used to gather and submit data had to meet applicable regulatory requirements including 21 CFR Part 11 that deals specifically with electronic signatures, audit trails, and electronic records. Building such a system in-house would have compromised the company’s ability to meet the submission deadline and its ability to continue selling those devices in the US.

Solution

The company selected the Innovit MDM platform to master its UDI product data and submit to the FDA. The Innovit MDM tool has a GDSN Connector (for Global Data Synchronization) to the 1WorldSync data pool that served as a gateway to the FDA UDI database (GUDID). StrikeTru worked with Innovit to deploy a PIM software solution that mastered authoritative, electronic product records with appropriate data validation and access controls to maintain data. This helped the company comply with the FDA UDI regulation to submit UDI product data to FDA GUDID database.

Result

StrikeTru and Innovit delivered a PIM software solution that helped this firm comply with the FDA UDI regulation by submitting device product data in a timely manner. This system contained authoritative, electronic product records with appropriate data validation and access control mechanisms built-in that allowed the company to also demonstrate compliance with FDA 21 CFR Part 11 requirements – with regards to validation efforts, electronic records, audit trails, and electronic signatures. The company also made plans to leverage the Innovit PIM solution to master all of its product data, orchestrate product data management workflows, and integrate the PIM system with other enterprise systems (PLM, ERP, etc.).