Leading manufacturer with operations in 70 countries and sales territories worldwide, this company evaluated multiple PIM software solutions to re-platform its existing PIM software for its Global Data Synchronization Network (GDSN) operations.

Challenges

This manufacturing company used the GXS system with a GDSN connector to aggregate and publish product data to the GS1 Global Data Synchronization Network (GDSN). GXS was going out of support and needed to be replaced. This company’s customers, many of who are large US retailers, depended on GDSN to get new and updated product data routinely, and an interruption here would have impacted sales negatively. Being a large global company with multiple business units, this manufacturer had complex product information management and data synchronization requirements and needed a robust PIM/MDM tool with a GDSN connector to meet its needs.

Solution & Implementation

Innovit MDM solution was chosen as the system to replace GXS. Pivox Labs worked with Innovit to define customer’s requirements for an improved PIM/MDM solution that was to replace GXS GDSN connector functionality and provide improved data management and GDSN capabilities. There was also a need to develop in Innovit MDM additional GDSN reports and enhancements to match current GXS features and provide easy visibility into the status of data synchronization with the company’s trading partners (i.e. customers).

Outcome

The company was able to migrate its GDSN operations from GXS to Innovit MDM before support for GXS ran out. The company also benefited from the enhanced usability and data management features that the Innovit tool provides via its intuitive user interface, data staging, and built-in GDSN data validation capabilities.

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.

Challenges

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 & Implementation

Company selected innovit MDM platform to master its UDI product data and submit to the FDA. 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). Pivox Labs 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.

Outcome

Pivox Labs and Innovit delivered PIM software solution that helped company to 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. This company also made plans to leverage 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.).

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