ROBAR Enterprise Labeling Software

ROBAR End-To-End Labeling

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GUDID

• Direct access to the FDA GUDID database utilizing the electronic submission gateway (ESG).
• Utilizes AS2 and HL-7 protocols.
• Ability to post hundreds of items with just a few clicks.
• Pre-submission validation of FDA rules.
• Business process workflows to manage submissions and error corrections.
• Maximizes data reuse.

EUDAMED

GDSN

• GDSN is becoming a requirement for commercial and regulatory compliance.
• Utilizes AS2 and HL-7 protocols.
• Content in GDSN is different to what is required for regulatory compliance.
• Project has been initiated for electronic communication between ROBAR master data and the GHX data pool.

OTHER

• Several countries such as Canada, Saudi Arabia, Australia and Turkey have indicated that they are planning a regulatory database similar to the GUDID and EUDAMED.
• Plug-in architecture is ideally suited to managing data and communicating it to any external database.

OTHERS

Oracle JDE and Other ERPs

SAP

• ROBAR has several flavors of interfaces to SAP.
• Utilizing pull technology at print time, data can be retrieved from SAP through remote function calls or execution of SOAP calls to existing services.
• Push technology can also be used by dropping XML files into folders based on events in SAP.
• SAP can also initiate print activity without any additional operator involvement. For example, raw material receiving can trigger the printing of appropriate barcode labels.
• Supports web services.

ERPs

Oracle/JDE & Other ERPs

• ROBAR is currently interfaced to several brands of ERP systems.
• Even within the same implementation of ROBAR, the system can be interfaced to any number of ERP systems, which often come into play as the result of acquisitions and mergers.
• Both push and pull interfaces are supported utilizing web services and direct database access through ODBC and linked servers.
• A concept called “Print Entity” is used throughout to segregate data from each ERP system.

PLM

• Single source of truth for labeling data is often a discussion at companies that have a PLM system.
• Utilize a SOAP interface for PLM data update when content is maintained in a different source system.
• Labeling system can combine labeling content kept within its database and master data communicated through the PLM SOAP to generate labeling.
• Evidence of labeling approvals and part numbers can also be communicated to the PLM system through the SOAP interface.

ROBAR SaaS or On-Prem

ENTERPRISE SYSTEM

• Microsoft .NET technologies
• Redundant servers with fail-over allow for 99.99% up-time
• Unlimited scalability through addition of dedicated print servers
• Active Directory Integration
• Browser-based access
• Full 21 CFR compliance capabilities
• Audit trail and electronic signatures
• Complete Validation Package

ROBAR DATA MANAGEMENT

• Completely configurable database with column level attributes and security. • SMEs can add data columns as new economic or regulatory mandates require it. • Browser based data management. • Supports each department maintaining their own data while automatically managing task dependencies. • Can be a repository from other sources of truth. • SOAP interface for integration to PLM and ERP. • Integrated approval workflow. • Web based translation dictionary with approvals. • 21 CFR Part 11 compliance. • Automated connection to GUDID, GDSN, and EUDAMED.

ROBAR LABELING MANAGEMENT

• Data merged with label templates at print time.
• Version control and locking for templates and data.
• Markup & side by side redlining.
• Integrated workflow approval.
• Automated 100% label inspection for verification and barcode grading.
• Complies with current, and will comply with future regulations.
• eIFU and implant card integration.
• Serialization integration.
• Mass template and labeling content change capabilities.
• Full 21 CFR compliance capabilities.
• Complete audit log with reprint capabilities.

Internal Printing

BROWSER BASED ACCESS

• The vast majority of ROBAR functionality is managed through the browser.
• The greatest benefit of this methodology is the ability to provide secure access to remote locations and third party business partners who are not on the network.
• Print operations across the Internet have opened the door for centrally managing labeling at third-party business partners and distribution centers.

LABELS

• Over 6000 types of printers are supported by ROBAR labeling.
• Unique methodology allows the same label template to be printed at dozens of different brands of printer.
• Utilizing a database merge at print time, the same template can also be used for thousands of SKUs that share the same label format.
• All barcode and graphical image formats are supported.

IMPLANT CARD

• This new requirement of the MDR is fully supported by ROBAR.
• While the final method of implementing implant cards is currently under debate, it is universally understood that a card will need to be printed at manufacturing time and will need to point to additional detailed information on a company website.
• The card is simply another output of ROBAR and can be linked to the eIFP (Instruction For Patient) hosted by Innovatum partners.

DOCUMENTS

• ROBAR can also support managing and printing of documents such as IFUs, COAs, inserts, etc.
• This capability is most significantly used in the Destination Labeling module of ROBAR.
• Appropriately translated labels and IFUs can be generated based on the destination of product being picked at the distribution center.

CLOUD OFFERING

• Systems can be hosted in the cloud, either managed by internal resources or by experienced vendor professionals.
• eIFU has become significantly more accepted and in fact, somewhat of a requirement.
• eIFP is a new concept which is needed to satisfy the MDR regulations around patient implant cards and the information that must be available to them.
• Innovatum has services to support electronic documentation.

cloud, crescent moon, and earth clipart picture

eIFU and ePatient Leaflet

BROWSER BASED ACCESS

PATIENT INFO

• Instruction for Patient (IFP) is a new concept growing from the MDR requirements for patient implant cards.
• Detailed content written at a level that can be understood by patients and with appropriate translations will be hosted on a company website.
• Innovatum in partnership with existing eIFU service providers will provide the infrastructure to link the implant card and the appropriate eIFP.