Tag Archives: compliance

Have you started planning for UDI compliance?

Class II and Class I UDI compliance deadlines are rapidly approaching. Does your strategy enable your business for long-term success? As a 1WorldSync customer you can add easily add UDI compliance to your existing subscription. You’re already exchanging trusted, accurate product information with your trading partners – why not use that process to send UDI compliance product information to the FDA?

Join the ranks of leading medical device manufacturers that are leveraging 1WorldSync to implement product information strategies for UDI compliance and beyond. Want to learn more?

Attend our informative webinar, How to Turn UDI into a Competitive Advantage, hosted by 1WorldSync Healthcare Industry Expert Todd Simons and Nada Savatic of Abbott Laboratories. Ready to get started today? Sign up for the 1WorldSync UDI solution or come visit us at Booth #6 at the FDA UDI Conference April 18-19 in Baltimore, MD.

Streamlining the Global Healthcare Data Supply Chain to Comply with Safety and Traceability Mandates

Article originally featured in Pharmaceutical Compliance Monitor.

The demand for robust product information is pervasive. It touches every industry and comes from multiple facets – end consumers to global governments – and the healthcare industry is no exception. Patients are no longer simply recipients of care, but active participants requiring access to rich product information to make informed decisions about their health, care and wellness.

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Roses are red, violets are blue, I love chocolate but I’m allergic to glu (ten)

‘Tis the season. You romantics might know it as Valentine’s Day, but for us chocolate lovers, its chocolate month. It’s everywhere you look. Giant and small, in heart-shaped and square boxes, accompanied by various t-shirt wearing stuffed animals, and in weird and wonderful shapes (I’m looking at you chocolate heart-shaped key). For a chocolate lover like me, this has always been the most wonderful time of the year…until this year. When I found out that I have an intolerance to gluten, I was afraid it was going to put a bit of a damper on my ability to indulge in the libations of the season. Lucky for me, the U.S. FDA has a law requiring gluten-free products to be labeled, so I know exactly which chocolate heart-shaped keys I can happily enjoy, and those that I can’t. This got me thinking about my beloved chocolate, and labels, and what ingredients are in the products I know and love.

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Regulatory Compliance and Beyond

Globally, businesses are experiencing the same challenge: they need robust, trusted, accurate product information. Consumers are demanding it, trading partners are requiring it, and governments are mandating it. While meeting consumer and customer demands are certainly a driver for change, regulatory mandates with tangible repercussions for non-compliance push businesses into action.

Organizations all over the world are being driven by local, federal, and global regulations to streamline their product information distribution systems for accuracy and transparency. Its impacting multiple industries; EU1169 in the foodservice and FMCG/CPG industry, UDI in the Healthcare industry, GHS in the DIY/Hardlines industry. Organizations are being compelled to act and in the process of assessing the scope and impact, are seizing the opportunity to achieve additional benefits.

Global organizations are seeing that readying product information for regulatory compliance comes with valuable byproducts. As internal systems are evaluated and streamlined to achieve compliance, additional business benefits are being achieved; supply chains are becoming optimized for efficiency, processes for data quality and accuracy are being implemented, and e-comm initiatives are being powered and supported. Product information is becoming rich, robust, accurate and readily available to customers and consumers alike, and businesses are becoming more efficient, compliant, and transparent.

Mondelez International is a shining example of how readying product information for regulatory compliance can transform systems and enable trusted, transparent product information exchange. Their approach of implementing a single global solution across all markets not only prepared their data for EU1169 compliance, but empowered their business for critical omni-channel initiatives. Read more about how Mondelez International met their regulatory deadline and then some!

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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Be Efficient. Be Compliant. Be Transparent.

This year more than 250 1WorldSync community members gathered in Austin, Texas for 1WorldSync Annual User Group, Americas to collaborate on hot topics under the theme: Be Efficient. Be Compliant. Be Transparent. With informative sessions addressing key industry pain points relating to supply chain efficiencies, regulatory compliance and any channel commerce, Annual User Group, Americas attendees heard how leaders in their community are addressing challenges and empowering their businesses for trusted product information exchange. As part of the dynamic agenda, fourteen 1WorldSync customers took the stage to share their success stories and attendees were treated to a special preview of The Attribute Graph (TAG) by 1WorldSync’s Chief Marketing Officer, Nick Parnaby.

The Fifth Annual Power of 1 Awards rounded out the event with General Mills, The Kellogg Company, Knights Apparel, McDonalds, Mondelez International and Walgreens each taking home an award for their significant contributions to product information exchange initiatives and the 1WorldSync community.

As the Diamond Sponsor of GS1 Connect 2015, which was co-located with 1WorldSync Annual User Group, Americas, 1WorldSync enjoyed an array of opportunities to continue to build upon the Be Efficient. Be Compliant. Be Transparent. theme. 1WorldSync CEO, Nihat Arkan, introduced the Wednesday keynote speaker to the GS1 Connect audience and 1WorldSync was the primary sponsor of the Wednesday night networking event, GS1 Connect on Rainey Street. Attendees to the 1WorldSync booth experienced the product information journey in the digital world, attended informative Major Release 3 1:1 sessions and engaged with leading recipients Target Corporation, The Kroger Company, Sam’s Club, SuperValu and Walmart.

New for 2015, 1WorldSync launched the 1WorldSync Events App which brought 1WorldSync and customer collateral, as well as dynamic community engagement right into the hands of attendees. The overwhelmingly positive feedback has ensured that 1WorldSync Annual User Group, Europe attendees will enjoy a similar digital experience. All in all, the week was a great success and we are excited to extend that success to 1WorldSync Annual User Group, Europe in September!

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. 

1WorldSync & Clavis Insight: Benchmark Data Quality Study

clavis logo

Online sales are up *23 percent year over year from Thanksgiving Day through Cyber Monday due to the holiday shopping.  Therefore it is essential for product information to be accurate and complete so consumers can make smart buying decisions. That is why, 1WorldSync and Clavis Insight collaborated to identify the causes of inaccurate product data and in the course of this collaboration they have identified the opportunity to help customers to ensure the highest levels of data accuracy. Continue reading

Addressing Continuous Product Safety & Compliance – Cope is not a Strategy!

How does your business address product risk and compliance?    Are you simply coping from one regulatory mandate to the next… stringing several point solutions together as you go along, or is there a more holistic solution.   For most businesses, addressing product risk and compliance is not an easy one to answer and you are certainly not alone.  Collecting, storing, managing and validating product safety or risk-related information is not a simple undertaking.  Whether you are a medical device manufacturer preparing to comply with the upcoming FDA UDI regulations, a Foodservice brand owner selling your products in Europe enforced to comply with EU Food regulations (e.g. EU 1169 ) or a retailer facing demands for accurate, robust and legally compliant product information from consumers. The ability to control quality data and its distribution across a large network of external trading partners becomes an ever growing challenge.  With legal and regulatory drivers behind these needs, failure to manage product risk effectively is not an option, and can have a major impact upon your sales and brand. Continue reading