Comparing GUDID Submission Options

GUDID Submission OptionsPulling information out of the FDA GUDID is simple. The public can access information contained in the GUDID through AccessGUDID. The FDA, in partnership with the National Library of Medicine (NLM) has announced that through AccessGUDID, anyone can search or download information that device labelers have submitted to the GUDID about their medical devices. GUDID submission options, however, is an area in which a few options present themselves.

GUDID Submission Options

#1 – GUDID Web Interface

A free secure online portal known as the GUDID Web Interface is provided by the FDA and it enables medical device labelers to enter UDI data directly into the GUDID database. Device labelers may submit, search and retrieve information about their devices via the GUDID Web Interface, which enables structured input of information one DI record at a time. A few caveats though, if data is entered using the GUDID Web Interface, it must be managed using the GUDID Web Interface. This portal is most practical for companies with <100 different SKUs or catalogue items. A number higher than that requires a more robust approach.

#2 – Software as a Service (SaaS)

The vast majority of GUDID submission offerings that are available in the market today, fall into this category. These cloud based offerings create data silos between your enterprise based systems and a third party. They also create a need for setting up and maintaining multiple connections between your enterprise systems and your product labeling systems. Introduction of errors caused by data getting out of sync between labeling and upload systems is a very real possibility. Proving auditable history for 21 CFR Part 11 compliance and potential trace history is more complex when some of the history resides in the cloud and some of it resides in other systems. In many cases, cloud based technologies have the capacity to reduce complexity. However, when it comes to regulated data upload and management, SaaS greatly compounds complexity. The outsourced service model offered by some SaaS providers is merely a way to pay a third party for some of the increased complexity that their business model creates.

#3 – Licensing A System

Systems are available from a few providers and Innovatum provides the most complete, end to end UDI solution in the industry. Although the complete suite of Innovatum’s ROBAR product line includes the option of labeling design and print management capabilities we are limiting this article to a focus on regulatory data upload. Suffice it to say that with this solution, the same database and corresponding connections to existing production and business systems (PLM, MDM, ERP, RA, etc.) can be used for both labeling data and the upload and management of regulatory data. This also means that one approval management system can be used for both labeling data approval and regulatory upload data approval. This remarkably reduces approval management overhead for medical device manufacturers and relabelers such as 3PLs and contract manufacturers. The ROBAR master data management and communication components are intended to be licensed as an on-premise solution for companies that desire tight control of their data. However, the solution can also be deployed in the cloud very easily. ROBAR MDM is a focused master data management database that is specifically designed for regulatory data. It serves as a real-time conduit for regulatory data that coalesces information from various sources and maintains the history of that data in a 21 CFR Part 11 compliant manner. The one-time licensing fee and annual maintenance costs for this technology winds up being much more cost effective than SaaS or service based per transaction, per item, per company revenue models.

Ardi Batmanghelidj, Chairman of the AIM NA Healthcare Committee and President & CEO of Innovatum, Inc., to Speak at UDI Conference 2015

Cranberry Township, PA – May 21, 2015 – AIM North America (AIM NA), the industry association and authority on barcode, RFID, RTLS, NFC and mobile computing, has announced that representatives of the AIM NA Healthcare Committee were chosen to be featured in a general session for the upcoming 7th Annual UDI Conference in Baltimore, Maryland, June 24th – 25th.

Representatives from the AIM NA Healthcare Committee will present Auto ID Technologies & In-House Systems for UDI Compliance during the first day of the Conference, which highlights The Reach of UDI. The session has been designed to showcase the automatic identification technology options which enable compliance with the UDI Regulation issued by the Federal Drug Administration (FDA) in the U.S. It will provide not only live demonstrations of the technologies at work, but discuss how to make the best choices which will most benefit a specific business.

Speaking on behalf of fellow colleagues and presenters, Ardi Batmanghelidj, Chairman of the AIM NA Healthcare Committee and President & CEO of Innovatum, Inc., said,”The opportunity to present live technology demonstrations while also delivering valuable information on how to best use and implement these various technologies, will not only help in UDI compliance for the FDA, but offer valuable insight on how automatic identification technologies can benefit businesses beyond compliance. Our presentation team will certainly represent a unique perspective to the audience at the Conference and show how the adoption of automatic identification is evolving.

In addition to the general session at the UDI Conference, AIM NA and its Healthcare Committee will have a significant presence throughout the event. Many of the exhibitors available to attendees during the conference will be showcasing their respective services and products. AIM North America will also host the AIM Resource Station featuring industry information and demonstrations of a variety of automatic identification innovations and technologies.

For more details on AIM North America at the 7th Annual UDI Conference, or to register, visit UDI Conference 2015 today. Special early registration rates are available through May 24th.

About AIM North America

AIM North America is the industry trade association that represents the Automatic Identification and Mobility industry in the US, Canada and Mexico. AIM North America provides education, news and information, legislative affairs, and marketing resources to grow the businesses of the industry’s resellers, systems integrators, solutions providers, manufacturers, and distributors. AIM North America is a chapter of AIM, Inc., the worldwide authority on automatic identification and mobility for more than 40 years.

For more information, contact the AIM North America office.

20399 Route 19, Suite 203, Cranberry Twp., PA 16066 |+1 724 742 4473(Phone) | +1 724 742 4476(Fax)

Visit us at  AIM North America

Ardi Batmanghelidj, AIM North America Professional of the Year

Ardi Batmanghelidj, President & CEO of Innovatum, Inc., headquartered in Sugar Hill, Georgia was selected as AIM North America Professional of the Year. Mr. Batmanghelidj has been a significant contributor to AIM’s work in healthcare and regulatory compliance, most recently serving as Chairman of the AIM NA Healthcare Committee. He is a published author and renowned industry speaker, providing expert guidance to the FDA and manufacturers in the area of master data management, labeling and barcoding. As one of the authors of the AIM white paper on UDI, he has been immersed in gauging the impact of serialization and UDI and has been assisting the industry toward compliance.

Established in 2007, the AIM North America Professional of the Year is presented annually to an individual in recognition of innovative and exceptional contributions to the development of the Automatic Identification and Mobility industry through their work as a contributor, collaborator, or mentor.

QuickLabel Systems And Innovatum Present Jointly

Ardi Batmanghelidj, President of Innovatum and Eric Pizzuti, Vice President and General Manager of QuickLabel Systems recently conducted a presentation called, “Achieving Compliance Agility With A Color Enabled Off The Shelf Label Management System” during the 2013 Medical Device Global Labeling Strategies Conference held in Minneapolis. Continue reading

Astro-Med’s QuickLabel Systems Forges New Partnership With Innovatum

WEST WARWICK, RI – QuickLabel Systems, a business unit of Astro-Med, Inc., has announced a marketing agreement with Innovatum by which they will actively promote one another’s products. At the heart of the new agreement is an understanding that Innovatum’s ROBAR Enterprise Label Management System and QuickLabel’s Kiaro! inkjet label printer combine to form a complete FDA-compliant color label printing solution. Continue reading

Innovatum Corporation Joins AIM – Signals Commitment to Automatic Identification and Mobile Solutions

Innovatum announced today that it has joined AIM, the worldwide association for Automatic Identification and Mobility. AIM works to increase the understanding and adoption of Auto ID, RFID and enterprise mobile computing through education, standards, and cooperation with other leading industry associations. Continue reading

Serialization- A Worldwide Challenge published in ISPE magazine.

The International Society for Pharmaceutical Engineering – (ISPE) – a Not-for-Profit Society whose purpose is to further and promote the interests of professionals in the Pharmaceutical Industry including Regulatory Agencies and Academia – has published an article that was co-authored by Innovatum’s Dana Buker in the ISPE Sept/Oct 2012 magazine which focuses on packaging. Continue reading