Tag Archives: UDI

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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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

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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Tweet the expert

Tweet the expert – join our interactive sessions at the Annual Congress 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.
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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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The Digital Footprint

As a PIM Practice Lead in 1WorldSync’s Professional Services organization, I have over a decade of experience in supply chain technology. I’m a seasoned expert in data synchronization and advise clients regularly on GS1 Standards and GDSN, while leveraging 1WorldSync’s solutions and partners to meet the ever-growing product information demands of businesses.  Continue reading

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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