Tag Archives: FDA

Food Safety has Life-Altering Consequences

History was made this week as a former CEO received the largest penalty ever for a food poisoning outbreak case because his product contained a deadly disease. This ruling will inevitably cause a fundamental shift in how future outbreaks are handled, by the courts and the foodservice industry alike. Food manufacturers are now on high alert that there are major repercussions for not complying with food safety regulations.

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The FDA wants YOU – to be compliant

September 24th 2015 is upon us, thus the second deadline for UDI compliance has arrived. As a quick recap, the FDA is requiring all medical device product information to be submitted to their Global Unique Device Identification Database (GUDID) in order to more easily and accurately identify and trace medical devices along the supply chain. (You can find out more about the regulation and compliance deadlines here.) Continue reading

Transformer le paysage mondial des soins de santé

Cet article est paru initialement dans le magazine Supply & Demand Chain Executive le 20 juillet 2015.

La publication d’informations produit erronées sur la chaîne d’approvisionnement peut avoir de lourdes conséquences, en particulier dans le secteur de la santé où elles peuvent faire la différence entre le bien-être et la maladie, la vie et la mort. Ces dernières années, la diffusion d’informations produit défectueuses a eu des répercussions sur la chaîne d’approvisionnement des soins de santé. L’industrie a ainsi dû faire face à des défis significatifs avec pour conséquences une augmentation des coûts de fonctionnement et un impact sur la qualité des soins fournis aux patients.

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The Power of 1WorldSync Product Information Cloud

As an avid reader of Bloomberg Businessweek, I was excited to see cloud technology, code, data management, everything that we, 1WorldSync, live and breathe, dominating the June 2015 issue. It got me thinking, how do we as a world, as an industry, as a business, educate decision makers on:

  • ‘Understanding and unlocking’ the value of the cloud?
  • Understanding the power and presence of data?

It is a new frontier, a ‘Data Revolution’, and the healthcare industry, specifically, is on the proverbial cliff ready to jump in head first. With the ongoing transformation of the U.S. healthcare delivery system, supply chain has become a key component to meeting organizational goals by driving clinical value, implementing innovation, and delivering operational efficiency. In order to fulfil its multifaceted objectives, supply chain is engaging with various stakeholders in pursuit of a common mission to foster a coordinated healthcare delivery system. Specifically, the impact of the ‘Data Revolution’ and the ‘Big Data’ explosion on the healthcare industry has spurred the creation of governmental and regulatory mandates, such as the Unique Device Identification (UDI) regulation set forth by the FDA. The UDI regulation require all medical device manufacturers to publish complete and accurate product information to the Global UDI Database (GUDID). To comply with the regulation, all medical device manufacturers must publish all required medical device product attributes to the GUDID by the specified time or face strong consequences.

Whether it’s in the form of regulatory compliance, seamless deployment along the supply chain, expanded storage, or collaborative networks or solutions, companies and businesses are looking to improve their top and bottom lines, and trusted product information is proving itself as a time and cost saver with the ability to help businesses grow. This is the core of 1WorldSync services and solutions. By building genuine business relationships and developing detailed strategic solutions 1WorldSync services address the most critical challenges within organizations in support of supply chain efficiency and regulatory compliance.

Join 1WorldSync at AHRMM15 to explore key ideas, trends, and best practices around building strategic stakeholder engagement, with an emphasis on supply chain perspective. Visit 1WorldSync at booth 924 and learn how the leaders in data pool management solutions and services can support your business for trusted product information exchange.

We look forward to seeing you there!


OUR Mission:

To be the Healthcare industry leader in product information exchange and the change agent that drives the industry forward through global regulatory compliance and improving healthcare standards.

Transforming the Global Healthcare Landscape

Blog originally featured in Supply & Demand Chain Executive business magazine on July 20, 2015.

The effects of inaccurate product information across the supply chain are tremendous, particularly in the healthcare industry where its implications can mean the difference between wellness and illness, life and death. In recent years, the impact of flawed product information ricocheted through the healthcare supply chain, resulting in significant challenges to the industry, driving increases in operational costs and impacting the quality of patient care.

Healthcare reform, increased transparency and traceability requirements, and poor data quality are just a few of the elements that are contributing to greater costs of doing business for healthcare organizations. In the meantime, product recalls, market withdrawals and safety alerts weakened government and consumer trust in the industry, resulting in greater scrutiny and heavier governmental regulation. In an industry that is global by nature, the necessity for a standardized approach to supply chain management is imperative to keep costs down, and ensure the safety and well-being of end recipients.

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Transparency – The New Consumer and Corporate Social Mandate

For some time now we have been living in an era of Transparency. Transparency in our policies and procedures, transparency in the business practices we operate, and transparency in the products and services we buy in business and in our daily lives. The transparent manner in which consumers expect to discover, buy and express opinions about products or services is the new norm for any business that expects to flourish in the mobile social economy.

Product information is in demand throughout the entire discover-to-review lifecycle, and at virtually every touch point of the consumer experience. Understanding the importance and value of product information transparency and its accessibility is simple, however, delivering it efficiently and seamlessly is anything but simple. Businesses must revisit the manner in which product information is created, exploded, standardized, quality assured and syndicated to all parties that enable the consumer experience.

Consumer demand for transparency and accountability is forcing businesses and entire industries to revisit the way product information is sourced, aggregated, distributed and labeled. Years ago, the seller was in control as purchase decisions were based on the availability, convenience and brand. The paradigm has shifted, and with an abundance of choice in front of them, consumers are making selections not simply on brand or availability, but on the attributes about the product. 

Compounding this even further, a plethora of global legal and regulatory mandates have been put into place, requiring Brand Owners and Sellers to comply with product information centric regulations. For example, EU Food Regulation 1169 or FDA’s Unique Device Identification. Such regulations are another compelling force for companies all around the globe to take a closer look at the digital information chain that accompanies their products as they pass along transitional and new Omni-channels to market.

For 1WorldSync, product information transparency gets to the heart of everything we do. Our mission is to empower global businesses and consumers with trusted product information that enables improved decision making, efficiency, health and well-being.

Our Product Information Cloud platform purpose was built to deliver syndicated product information solutions and services to customers around the globe that rely on product information to power their businesses. For many of our 16,000 customers, the ability to mobilize a product information transparency program is a logical next step on top of the solid product information management foundations they have built with us over the last decade or more.

Every industry we operate in is actively investing in software and processes transformation that enables transparency. From the product development, to aggregation and management of product data at the manufacturer to setting up an item for sale at a retail or online store, to presenting that information to the consumer.

It is such a hot topic this year that we have made it the focus of our annual customer user conferences in both the USA at GS1 Connect, and in our EMEA customer event alongside ECR Europe this year. 

Shifting paradigm in healthcare

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.

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Annual Congress 2014 Cologne

1WorldSync Annual Congress – Stay Connected!

One of my favorite events at 1WorldSync is the Annual Congress in Cologne, Germany. Last year, I was impressed by the variety of topics and in-depth individual sessions. Annual Congress provides insights on how having accurate product information can open many doors for your company.

1WorldSync’s Annual Congress which will be held on September 30 – October 1, 2014 provides a platform to inform, share and listen to customers and partners and provide holistic answers to questions that arise from increasing industry challenges. It’s an exciting two days of collaboration, so get ready!
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I’m not sure what UDI stands for, how will my Organization be ready for compliance?

A recent United States Food and Drug Administration (FDA) regulation, issued on September 24, 2014 has medical device manufacturers on a global basis, readying their organizations for compliance. The new regulation requires most medical devices to be marked and labeled with a unique device identifier (UDI) and then entered into the FDA’s Global Unique Device Identification Database (GUDID) with a set of FDA-specified attributes.  Compliance dates are driven by the class of medical device. Continue reading