A ground-breaking white paper: Compliance with UDI Labeling Mandates: A Proven Methodologyby sterling1 on Mar 9, 2010 • 7:53 am No Comments
We have a brand new and very compelling White Paper just out. Compliance with UDI Labeling Mandates: A Proven Methodology, was produced because, as the introduction states: There has never been a better or more urgent time for manufacturers of healthcare products to make a close examination of their product labeling systems.
If you read just the first paragraph and juxtapose what it says with your current product labeling solution and/or objectives going forward, chances are good you’ll want to examine the whole document. First, it answers the question why this is the most urgent time and then delivers a blueprint for finally solving most, if not all, of the long-term legacy labeling implementations that in our experience just are not up to what’s coming… soon.
For your convenience, here’s the paragraph that will tell you immediately if you should read on, and will validate for you that from long years of experience in product marking, Loftware is providing the industry’s thought leadership today when it comes to Unique device Identification (UDI) in healthcare — with whatever labeling standard may ultimately be adopted. In answer to the question why this is an urgent time:
Why? Because in most cases, existing solutions were developed over time, usually organically and often departmentally, individually and separately by each manufacturing entity to a labeling standard of their own choice. This approach has mostly worked, albeit at great expense, with much inefficiency, and at the tremendous risk of error, manufacturing interruptions, counterfeit labels and a host of other problems. But in addition to these well-known limitations, there is one additional major reason why now is a good time to explore labeling solution alternatives. New labeling mandates from the FDA – now expected to be imposed no later than September, 2013 – are going to require all healthcare products manufacturers in the United States to adhere to a uniform set of Unique Device Identification (UDI) labeling standards. This means that proprietary labels and any labels that are not part of a universally-accessible database for common use by all other manufacturers and at all checkpoints in any supply chain will, virtually overnight, be a thing of the past in the United States. In fact, it is likely the FDA initiative will further drive the global effort occurring at this time to effect this same kind of UDI solution worldwide.
Read on and you’ll see the steps in our recommended and proven methodology for solving these issues. They include Consolidation, Integration, Automation, Validation and Ongoing Support. And don’t miss the important side bar on Loftware’s position on GS1 for which the Company maintains an agnostic view. The side bar explains why waiting for a standard to be named by the FDA within the next three years poses no barrier to starting to fix problems now. To access this major new White Paper, go to this link, which also provides access to our series of webinars on our UDI methodology.
Lastly, a brief word about the Authors. The authors of this Loftware White Paper are Michael Rennell, Senior Vice President, Global Sales and Marketing, and Christopher Piela, Director of Healthcare Solutions. Mr. Rennell, with over 30 years in Information Technology, brings a depth of understanding to the current evolution of convergences in infrastructure technologies and regulatory mandates. He has extensive experience in the deployment of major enterprise business solutions, coupled with significant expertise in compliance labeling technologies. In the last 5 years he has assisted organizations worldwide to prepare for the adoption of emerging technologies addressing requirements for IT centralization and consolidation as well as risk reduction tied to the increase in regulatory mandates.
Mr.Piela draws his unique perspective and knowledge of healthcare product labeling opportunities from more than 17 years experience in which he has worked in a wide variety of healthcare roles that span a cross-section of the healthcare supply chain. His experience includes 9 years with a major life sciences manufacturing company where he specialized in validation systems. Later for approximately four years he was with a major provider of hospital operational services where he became immersed in the patient side of healthcare products and services. And, for more than four years, as Loftware’s Director of Healthcare Solutions, he has established Loftware’s presence and reputation worldwide in this highly specialized vertical with dozens of major, brand name healthcare products and services providers.
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