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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.

GDSN

• GDSN is becoming a requirement for commercial and regulatory compliance.
• 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.
• Availability expected early 2019.

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.

Other

 

SAP

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.

Oracle JDE and Other 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

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

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

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.

 

Label

LABELS

• Over 4000 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

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

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.

eIFU and ePatient Leaflet

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.

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.

 

Patient Info

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.

Provider Info

Provider Info

• 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.

 

3rd Party and DC 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.

 

Label

LABELS

• Over 4000 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

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

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.

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.

Contact us for more information.