Tag Archives: Regulation

1 Solution – Global Healthcare Compliance

The healthcare industry is evolving and the ability to control trusted quality data can be challenging.

If you manufacture or supply medical devices or pharmaceuticals, then you’ll need to comply with multiple regulations in the near future. Whether it’s for the public sector (NHS in the UK), Group Purchasing Organizations, Regulation in Europe (MDR and IVDR) or in the US (FDA GUDID) – there are strict new regulations and customer demands you must meet in order to continue to do business. Continue reading

Back to School Blues: The Chore of the Daily Lunch

The sunscreen bottles are nearly empty.  The luggage is stored in the garage (and if you’re lucky, the in-laws safely on their way back home).  We’ve binged watched every show in our queue and eaten the last of the season’s crop of good peaches.  Summer is this close to being in the rear view mirror.

Yes, and right around this time of year, as we vacuum out the beach sand, crushed potato chips and summer-old food wrappers from the inside of our cars, we are officially in ‘back to school’ mode.  For some it’s cause for cheering, (the kids go back to school after all), for others it’s a reminder of the long list of upcoming to-dos and calendar commitments (think soccer practice, school plays and scout meetings).  And aside from the obvious back to school prep work of clothes, books and school supplies, there’s the added chore of the daily lunch routine.

Are you going to stock up on lunch box supplies or will your kids buy lunch? Chances are that you’ll be one of approximate 60% of parents who opt for their school’s lunch program.  After all, parents are busy, kids are picky.  But fortunately, school lunches have become tastier and healthier.  In fact, a good deal healthier.    Most school districts now offer healthier food and beverages in vending machines, school stores, and a la carte cafeteria lines. Fruits, vegetables, water, and hundreds of nutritious snack products now fill these venues instead of the candy, sodas, and other unhealthy items that were commonplace less than a decade ago, mostly because of consumer demand and updated regulations.

Of course, that same demand is driving a level of clarity and transparency into what their kids are eating.  They ask questions and read labels.  So what exactly are parents looking for?

  1. Hidden Trans Fats

Over the next couple of years, food companies must phase out partially hydrogenated oils – a major source of artery-clogging trans fats – under a recent directive from the Food and Drug Administration. Until then, consumers are checking food labels for the word “hydrogenated.” If an ingredient list includes this kind of oil, but the trans fat amount reads zero, watch out.

  1. Genetically Modified Organisms (GMOs)

Over 64 countries now require GMO labeling. Though studies have not determined that GMOs are harmful to eat, many consumers are concerned: limited research into their safety, a rise in “superweeds” that resist the herbicides used on GMOs, and, consequently, more overall pesticide use.  So consumers are voraciously reading labels and looking for ‘USDA-certified organic’ or the “Non-GMO Project Verified” seal on the label.

  1. Wood pulp

That is not a typo.  Wood pulp is often lumped under the heading of ‘added fiber.’   So again, consumers are combing food labels for “cellulose” and “cellulose powder”.

  1. Allergens

Studies show that 16%–18% of children with food allergies have had a reaction from accidentally eating food allergens while at school. More than 170 foods are known to cause IgE mediated food allergies. In the US alone, eight of these foods or food groups account for 90% of serious allergic reactions: milk, eggs, fish, crustacean shellfish, wheat, soy, peanuts, and tree nuts.  Fortunately, federal law requires food labels to clearly identify the food allergen source of all foods and ingredients.

School organizations such as North Carolina Department of Public Instruction (NCDPI) are beginning to leverage the increased amount of available product information as well as detailed nutrition labels to mitigate the risk of allergic reactions among students. By utilizing the 1WorldSync Digital Catalog of product information, updated straight from the source, NCDPI is able to comply with USDA federal regulation for meal pattern requirements and easily distribute it this information to parents, students, and even healthcare professionals upon request.

Whether or not students choose to pack or bring their lunch this year, one thing is for certain: their decision will depend on the amount of available product information. It is clear that consumer demand for transparency far exceeds just the Consumer Packaged Goods and Grocery industries, but also extends to any organization that distributes and sells their products to schools.

Click here to learn more about how 1WorldSync solutions can help the Foodservice industry provide product information transparency.

Are you ready for UDI compliance?

This free workshop provides insight for how your business can comply with the FDA UDI regulation. You will learn about:

  • how to transform compliance into a competitive advantage?
  • what are your obligations under the FDA UDI regulation (Class I and Class II products)?
  • how leading manufacturers successfully use 1WorldSync solutions to efficiently manage those challenges
  • Audience: Supply Chain, Data Quality and Regulatory Affairs managers
Register today

 

These workshops are free and seats are limited:

United Kingdom

Date and Time: 23rd June 2016, 10:00 a.m. to 12:30 p.m.
Location: Leicester Marriott Hotel, Smith Way, Grove Park, Enderby, Leicester, LE19 1SW UK
Register now

Germany (this workshop is held in German)

Date and Time: 23.06.2016 10:00 – 13:00 Uhr
Location: Tuttlinger Hallen – Tagungsraum 1,
Am Europaplatz – Königstraße 39, 78532 Tuttlingen
Register now

France (this workshop is held in French)

Date and Time : 28.6.2016, de 9h30 à 12h00
Location: Centre Regus Opéra, 27 avenue de l’Opéra, 75001 Paris
Register now

Are You Ready For FDA UDI Compliance?

Take Our Interactive Assessment and Find Out If You’re Prepared to Meet the September, 24th, 2016 Class II UDI Submission Date

The deadline for Class II Unique Device Identification (UDI) submissions is September 24, 2016.  With only a few short months remaining, companies are faced with the significant challenge of locating tremendous amounts of product data.

The FDA has mandated an effort to improve the identification of medical devices such as blood glucose monitors to scalpels, which is expected to increase standardization, efficiency and most importantly, safety of patients. But, it does place an additional regulatory burden on device manufacturers.

Are you 100% confident that you’re ready for UDI compliance?

Take Our Interactive Assessment!

We Can Help! 1WorldSync Supports Compliance With FDA UDI Regulation
Leverage our experience and world-class solutions to save resources and quickly amplify your profitability. Our connection to the FDA Global Unique Device Identifier Database (GUDID) means that you’ll have trusted, accurate product information to comply with the UDI regulation.
WorldSync’s healthcare offering is a comprehensive solution to capture, manage and share your product information. Our solution empowers manufacturers to:

  • PREPARE product information to be compliant to FDA UDI regulations
  • CAPTURE and aggregate data across multiple countries and markets to ensure compliance with medical device regulations throughout the global supply chain, including International Medical Device Regulatory Forum (IMDRF)
  • MANAGE product information from multiple entry points to ensure complete and accurate information.
  • DISTRIBUTE product information using a timely, manageable and auditable methodology.

Talk To An Expert Today!

Whipped Cream with the certain something

In the current edition of german retail technology magazine, Marina Sennet, Director HazMat Compliance Solutions at 1WorldSync, writes on companies risks of missing a harzardous substances management and how to ensure to annul them.

Since 2015 european trade has new regulations to handle chemicals and hazardous substances. As it is extensive and difficult for trading companies to keep all safety data sheets up to date, 1WorldSync offers an appropriate service for that.

Continue reading

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.

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. 

Food Regulation Fruits

Regulation (EU) No. 1169/2011 is an Opportunity and not Just another Cost of Doing Business

“Boing” tolls the bell of doom. On 13th December 2014 another Grim Reaper of corporate IT budgets visits the European Grocery Market when the  Food Regulation (EU) No. 1169/2011 come into play. Or at least that’s the way some people I speak to are seeing these new regulations.  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