ROBAR

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ROBAR is an enterprise labeling and regulatory data management system built for life sciences manufacturers working under FDA and EU regulation. Innovatum has focused on regulated labeling for over 25 years, and ROBAR brings enterprise labeling, regulatory and product master data management, regulatory data submissions, and quality assurance together in one integrated product family rather than a set of partner-built integrations. Label content lives in a completely configurable database with column-level attributes and security, where subject matter experts can add data columns as new regulatory mandates require. Variable data merges with approved templates at print time, so one template format can serve up to 30,000 SKUs, and ROBAR natively supports 6,000+ printers. Average first label out is 3-10 seconds. ROBAR covers the full label lifecycle. Design and review are browser-based, with side-by-side redlining, comment tracking, and version control and locking on both templates and data. Approvals route sequentially or in parallel with notifications. Production includes automated 100% label inspection, mass template and content changes, and a complete audit log with reprint capabilities. Decades of labeling data stay instantly available without a need to manage and search archives. ROBAR submits directly to the FDA GUDID through the electronic submission gateway and connects to EUDAMED and GDSN, with capabilities spanning UDI, MDR, IVDR, and EUDAMED requirements. It handles MDR implant card printing, eIFU and eIFP, destination labeling with a web-based translation dictionary and approvals, IFU and Certificate of Analysis printing, and medical device and pharmaceutical serialization. The system is completely 21 CFR and Annex 11 capable with reporting, including electronic signatures, audit trails, and granular function-level security with Active Directory integration. A complete validation package is included. ROBAR interfaces with ERP, PLM, QMS, and MES systems, including SAP and Oracle/JDE, using SOAP, web services, XML, AS2, HL-7, and ODBC, with multiple ERP systems supported simultaneously in one implementation. Hosted and SaaS deployments are always single-tenant on dedicated servers, available on Azure, AWS, or Oracle, with on-premises also supported. Redundant servers with fail-over allow for 99.99% uptime. Licensing is browser-based with unlimited access licensing for the complete supply chain. Innovatum enhances its base software following GAMP 5 rather than producing customer-specific customizations. Support runs 24/7 across all time zones: phones are answered by people, all support is tier one from the project managers who implement the product, and problem resolutions come in minutes instead of days. The same software runs at companies with 25 employees and at companies with 250,000. Customers include Zimmer Biomet, Stryker, Bristol Myers Squibb, AstraZeneca, Sanofi, Smith+Nephew, and Gilead.