ROBAR Enterprise Labeling Software is an all-in-one system able to produce labels in a compliant part 11 manner with electronic approvals, digital signatures, and version control. As global UDI comes to the forefront of industry attention, we at Innovatum have worked closely with industry stakeholders to create solutions to match the rigors of regulatory data management and publication to governmental and economic databases. We are working to help many companies who are still using Excel to track UDI and other information, which is quickly becoming an untenable methodology. It is not Part 11 compliant, resulting in validation difficulty and a lack of a crucial audit trail.
Innovatum’s browser-based software boils data management in: configurability, auditability, ease-of-access, electronic signatures, and the ability to pass audits from FDA or other regulatory agencies. It allows for the addition of data columns for data elements that need to be addressed, such as the European Union’s BUDI and SRN. Users can open a configuration screen and click on a new tab. They can access labeling, regulatory data management, submissions, and many other features that make compliance a relative ease. Each division or group can be given a tab and access to define columns of data elements that need to be tracked. Going into ERP or PLM systems to make changes becomes unnecessary; it is simply a matter of a user (with the proper credentials and training) going in through ROBAR Enterprise Labeling Software’s simple infrastructure and making changes. IT does not need to be involved. Authorized users can add new fields and specify share-names, allowing for dynamically data-driven labeling, document creation, reporting, etc, and specific departments can even be given view security. The database can also be set up to track whatever is needed.
ROBAR Enterprise Labeling Software can be the source-of-truth for some data elements and it can be a consolidator for others. Information can be used for data mining, data enrichment, data analysis, and search criteria can be set up to retrieve it. With efficiency in mind, ROBAR can do a mass update, route labels for approval, and then make them live. It tracks GTINs within the system and manages them as they get assigned automatically calculating packaging levels and check digits. Trading partner uploads are done modularly through the Communication Manager, a generic manager, albeit one whose function becomes more specific based upon the accompanying target database plug-in being used. Posting hundreds of items for submission with just a few clicks along with acknowledgements becomes fluid. As soon as more information about EUDAMED is made available, Innovatum will be creating interfaces for registration and other required areas as well.
GDSN uploads are a necessity for UK’s Scan4Safety and Hospital buying groups that are forcing manufacturers to have their economic information in GDSN. Innovatum has just completed our project with GHX to facilitate these necessary data uploads.
Patient implant cards and associated hosted information must be available in the language of the health care location or of the patient. Innovatum labeling natively prints the implant card and we have a partnership with Qarad to host the patient leaflets as well as eIFUs.
In response to the added challenge of managing languages and translations, significantly magnified by the MDR/IVDR implementation in Europe, Innovatum has recently added the Destination Labeling module. This functionality moves a portion of language labeling to the customer order fulfillment step. Rather than manufacture for individual locations, the goal is to manufacture for 85 percent of shipping destinations and add supplemental labeling to satisfy the needs of the other 15 percent. Destination labeling allows for the scanning of package UDIs at the distribution center to print for customers that are varied by locale and individual local requirements.
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