Tag Archives: FDA

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

UDI: Generating Value Beyond Compliance

Getting to Good Data in the GUDID*

The United States Food and Drug Administration (FDA) regulation mandates that UDI data for Class I medical devices to be submitted with an impending deadline of September 24, 2020.  This has made medical device manufacturers on a global basis, readying their organizations for compliance. As a leading healthcare provider or manufacturer, do you find yourself asking yourself the following questions?

  • What is the scope of products impacted (exempted or not)?
  • What are my obligations under FDA UDI regulation?
  • How do I transform compliance into a competitive advantage?
  • How can I source my data from multiple locations, formats and systems, controlled by different functions?
  • How can I ensure the data I provide to the FDA is complete and accurate?

1WorldSync & Innovit Join Forces

Innovit,  a global provider of software solutions for PIM (Product Information Management), MDM (Master Data Management), GDSN (Global Data Synchronization) and Enterprise Workflow Management, and 1WorldSync™, the leading provider of product content solutions, possess a collaborative agreement to enable more robust product content capabilities for the medical device industry.

Whilst manual data entry or Excel spreadsheet upload may have been a viable solution for Class II & III submission deadlines, Class I poses a much greater challenge for labelers.  The sheer volume of products in this category makes manual submission methods too slow.  High product volume increases the burden of data collection, data cleansing and data entry to the GUDID.  The risk of failing to meet FDA’s deadline increases substantially.  

Innovit’s ‘UDI Multi-Connector’ is an automated, machine-to-machine data validation and submission system designed to address today’s needs for GUDID, as well as tomorrow’s needs for other global UDI recipients such as EUDAMED, NHS, and more.    

Whether your organization relies on a HIBC or a GTIN (or you’re looking for definitions on what those terms mean), 1WorldSync offers multiple solutions to send your data to the FDA. A primary benefit of submitting data through a 1WorldSync solution is that the data collected can be easily sent to other recipients, including GPOs, distributors, and other healthcare providers.

With the 1WorldSync UDI Solution, your business can prepare and validate medical device product information before the compliance deadline, giving you more time to focus on producing the quality products your customers and patients love.

One Process, One System and One-time Investment for Compliance. Advanced Readiness

Get ahead of the game and get back the time to focus on producing quality products your customers and patients love! For organizations manufacturing medical devices, 1WorldSync & Innovit experts can help organization prepare to meet the September 24, 2018 deadline through our comprehensive solutions.

Manufacturers can create a sustainable process to collect, manage, and distribute product content to all their UDI recipients, including FDA GUDID, EUDAMED, NHS, and others.

Make plans to visit Innovit and 1WorldSync at the UDI Conference taking place June 7-8 in Baltimore. Learn UDI implementation strategies and identify a sustainable process to successfully publish product content to the GUDID from our experts first-hand!

*GUDID – Global Unique Device Identification Database

UDI: One Cost for Compliance. Advanced Readiness

1WorldSync, the leading provider of product content solutions, recently entered into a collaborative agreement with ReedTech, a provider of data management and analytics solutions for the life sciences industry, to enable more robust product content solutions for the medical device industry.

1WorldSync™ & Reed Tech® Join Forces

Through the integration of data exchange capabilities from 1WorldSync with Reed Tech medical device product data management solutions, the two organizations together are able to offer device manufacturers a single full-service approach to device product data management.

“This collaboration will allow the medical device industry to receive expanded, customizable offerings to meet current and future challenges,” said Dan Wilkinson, Chief Commercial Officer at 1WorldSync. “Our agreement benefits customers of both companies, enabling more robust product content support to meet the continually changing mandates and regulations in healthcare.”

Ethan Eisner, VP of Global Commercial Markets at Reed Tech, also indicated his enthusiasm for the project. “Reed Tech is a leader for medical device product data management solutions, including Unique Device Identifier (UDI) regulatory filings to the FDA. Our organizations are well-aligned to offer superior value to our customers through a single solution capitalizing on the strengths and expertise of both companies. We are excited about the addition of GDSN capabilities into our medical device data management solutions.”

Generating Value Beyond Compliance

With a single, full-service solution from 1WorldSync and Reed Tech, you can feel confident in your company’s product content and rededicate your time to producing the quality products your customers and patients need.

1WorldSync and Reed Tech can help your organization manage and capitalize on the value of your product content, syndicating to trading partners to fulfill requirements of governmental authorities (such as FDA UDI and UK NHS eProcurement) and buyers (such as GPOs and influential hospital networks).

Visit 1WorldSync (booth #6) and Reed Tech (booth #20) at the UDI Conference in Baltimore June 7-8. Learn UDI implementation strategies and identify a sustainable process to successfully manage your device product content from our experts first-hand!

On May 23, Reed Tech and 1WorldSync will co-present a free webinar for industry members on how to meet the UK NHS eProcurement deadline and provide product data to buyers. Register now!

A Connected Lifestyle for 2017

We are all living a Connected Life in 2017.

Connected and mobile commerce is a way of life for us all and businesses are striving to leverage this connectivity to improve consumer safety, the customer experience and increased market penetration.   The growth of cross-channel commerce is a core component of every business plan, regardless of industry or geography.

Global market leaders embrace product content as vital to their engagement with business partners and customers.  Trusted content turns that engagement level into commitment.  Every business leader knows that more content is better, but what we have all learned is that trustworthy information is often the difference between loyal, repeat consumers and lost sales; or worse injury from lack of available product information.

The Smart Label initiative for consumer goods and EUDAMED and the FDA UDI regulations for medical device labeling initiatives, provide guidance for companies on which content is needed to aid patient safety and provide consumers with information to make health and wellness decisions.  However, in the absence of regulations, what content is needed, which channels, and how frequently?  These are problems many companies are challenged with in 2017.  Digital content is a requirement, not a luxury; and the proliferation of the content consistently remains obstacles to be overcome for all industries globally.

In the 1WorldSync data study launching in April, Charting the Course for Global Commerce, over 400 global respondents reported thirty-nine percent of merchants cannot support mobile commerce, and 68 percent have yet to integrate product information management capabilities across web, mobile apps and in store.  Establishing a connected commerce platform remains elusive for many companies.

The 1WorldSync Product Information Cloud solutions continue to evolve and leverage both industry best practices and best in breed technologies to assist our community in overcoming many of the connected commerce challenges: from UDI and Healthcare solutions in Asia, Europe & the Americas to Hazmat solutions and retail apps for increased sales and market penetration.

The Connected Life is a reality for consumers, patients, brands, suppliers, hospitals, governments, retailers and distributors….Everywhere, Every Day.

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!

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.

Continue reading

Technology, Transparency & Trust

The Three Pillars Defining Our Age

In our last blog, we discussed current pressures impacting the consumer markets, including the FDA’s Public Law 111-353 through its “Food Safety Modernization Act”, as well as from other governmental and ‘watchdog’ groups’ reviewing the food industry.

But we are now living in an age that is going beyond government mandates, because whether you are in the automobile or the peanut butter business, Transparency & Trust have become ‘headline’ concerns not just for regulators but ever more, and no less importantly, for consumers. And, in light of the latest news from the automotive industry, we must now acknowledge the irrefutable reality that there are, beyond government penalties, other consequences for brand equity and the managers who manage it.

In the recent past, most business have lived in the “IT” or Information Technology era, with an emphasis on the ‘T’- the technology aspect of the collection and storage of data. Advances in technology are now pushing us toward the Information (‘I’) age or Zettabyte epoch where the capture, storage and retrieval of information, and its access to all, is virtually unlimited. In this evolving new age, the mantra is … ‘If information can be known … it will be known!’

For today’s ‘Connected Consumer’, the entire universe of information is only a click away. Social media platforms, blogs and apps are keeping everyone constantly connected. Individuals increasingly feel the need to know—and share —everything. Whether its product reviews, political opinions, a family vacation, a dinner pic, or even their innermost thoughts, people are living their lives completely out in the open, laying bare all manner of minutiae online. And, while brands are noticing and looking for new ways to create corresponding connections they, too, are being laid bare.

As a result, consumers today are personally experiencing and demanding Transparency, before giving Trust. For a brand or a business, Trust from their customers and employees is critical. Transparency, is now an information technology mechanism that allows Connected Consumers access to information that defines a certain innate dissonance which always exists between disbelief and belief. Technology and Transparency therefore combine to determine the level –and increasingly a measurable level– of ‘Trust’ that is so critical to the success of a business and a brand.

Russell Ackoff, a noted academic and business consultant, often chided his students and clients to “stop doing the wrong things righter and do the right things.” Technology, Transparency & Trust are forcing marketplace change— a change that no longer allows a business to do the wrong things righter to enhance the P&L—it is a change that requires business to do the right things.

Hail the Consumer!

To learn more:
Brand
Etailer

As Global Vice President for the Consumer Markets, Michael Forhez, who recently joined 1WorldSync, brings 20 plus years of diversified experience in sales, marketing and management consulting. Frequently called upon to write and speak on subjects germane to the consumer markets, Michael is currently responsible for evangelizing 1WorldSync offerings within the Consumer Products and Retail sectors while engaging various stakeholders to better understand their collective requirements.

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.

Continue reading