GDSNを活用した米国UDI規制の対応

By | November 4th, 2014

UDIとは、Unique Device Identificationの略であり、米国食品医薬品局(FDA)による医療機器の識別に関するルールや管理システムのことである。2013年9月に、これに関する法令が制定され、米国における医療機器の製造、販売者はこの影響を受けることになった。 UDIの目的は、米国内で販売される医療機器を正しく識別することで、偽物の判別を容易にし、医療機器のリコールプロセスなど、医療業界全体の効率化を図るためである。すべての医療機器メーカーは、FDAのルールに従って固有の識別子を製品に付番することが求められ、ラベルやパッケージに表示することが義務付けられる。また、FDAが新たに構築するGlobal UDI Database(GUDID)に規定のデータを登録、維持することが要求される。UDIの対象となるのは、米国内で流通されるすべての医療機器であり、FDAが定めた管理クラスによって以下の通り対応期間が定められている。

1WorldSync’s customers have the convenience of having a “One Stop Shop”…

By | October 7th, 2014

Pam Hoock from Bunzl describes her experience with 1WorldSync’s Digital Asset Management capability Supply Chains are evolving to address the pressing needs of the digital economy. Businesses must respond to the demand for the exchange of digital assets, from high quality images, eCommerce thumbnails, product safety documentations, video and other digital media. 1WorldSync offers a powerful […]

Attribute Explosion and Data Quality in an Omni-Channel Global Economy

By | October 2nd, 2014

Cologne (Germany), Oct. 02, 2014 – 1WorldSync held their 5th Annual Congress at Cologne’s World Cup Soccer Stadium with 130 representatives from over 20 countries.  Industry experts drove discussions on consequences for increasing regulations, modified consumer expectations and new omni-channel strategies for multi-enterprise product information exchange. The annual congress brought together industry leaders from around […]

Tweet the expert – join our interactive sessions at the Annual Congress 2014

By | September 23rd, 2014

For the upcoming Annual Congress 2014 we are looking forward to giving our participants the opportunity to quickly raise questions, comment or give feedback on our twitter-wall, live and even during the sessions. Therefore please use the hashtag #1wsac – and add it to your tweets.

GDSN Attributes 101: A Quick Count

By | September 18th, 2014

There are 1,100 GS1/GDSN standard product attributes.  But don’t quote me on this.  That’s because the count is approximate, and growing.  More importantly, the 1,100 calculation requires several scoping and definitional qualifiers. A GS1/GDSN standard product attribute can be defined as a product item attribute that has been “approved” and “modeled.”  “Approved” means the attribute […]

Product Information Cloud Forecasted in Global Supply Chain

By | September 11th, 2014

In today’s fast pace business environment, technology challenges are increasing due to the ability to connect large numbers of trading partners around the world with accurate, authentic, timely data. With ever changing customer requirements companies have been forced over the last decade to become more dynamic and support the shift in supply chain architecture from manual […]

The Future of Social Commerce

By | September 9th, 2014

I think it is fair to say that commerce has always been a very social activity. Marketplaces have been a gathering place for people for thousands of years and word of mouth has always been a huge influence on what people buy. But as more and more people engage in social networking activities and platforms […]

The Commerce Metric That Matters

By | August 28th, 2014

E-commerce as a sales channel for the retail industry continues to grow. Currently, e-commerce accounts for about 6% of overall retail sales, and about 11% of the top 30 product categories, according to Forrester.  The growth rate of e-commerce sales is currently estimated around 15% annually, much higher than that of traditional in store sales. […]

Don’t Put the Accuracy “Cart” Ahead of the Completeness “Horse”

By | August 28th, 2014

Throughout time, grandiose aspirations have seemingly convoluted processes and procedures.  What exactly do I mean by this? The Foodservice Industry has been struggling with this balancing act for a number of years now. The balance between reaching an Ultimate Goal vs. Ability to Execute towards that goal. That balancing act has never been more tested […]

Shifting paradigm in healthcare

By | August 20th, 2014

1WorldSync had the great pleasure of attending the Annual AHRMM Conference August 3-6, 2014. There was a lot of valuable information shared, but above all, it was clear that the Healthcare Industry is well on its way to realizing the benefits of GS1 Standards and eventually, the GDSN.