Complying with the 21 CFR Part 11 rule

Posted by Jessica Plourde Hutter on February 12, 2016

In an increasingly complex market for pharmaceutical drugs and medical devices, manufacturers are relying on electronic systems to produce, store, ship and track their products. In particular, extensive barcode labeling systems are crucial for ensuring a reliable, accurate and traceable supply chain.

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Topics: Medical Devices

Why is training users important for barcode labeling?

Posted by Maureen Perroni on February 11, 2016

Training is a critical step in educating users and administrators on the capabilities and options available to them that can be employed to best meet the labeling requirements for the business. And, getting that training directly from the people who developed the solution offers a real advantage.

 

 

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Topics: Labeling

What's next for UDI Compliance? [Video]

Posted by Jessica Plourde Hutter on February 10, 2016

Last week, we discussed the importance of the FDA's UDI compliance and how they have applied to the medical device industry. Now we'll look at what comes next.

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Topics: UDI, Medical Devices

The disruptive force of “The Cloud”

Posted by Josh Roffman on February 9, 2016

The disruptive force of “The Cloud” was front and center at Oracle’s Modern Supply Chain Experience conference last week in San Jose, California. During this event Oracle presented its path for the future for its supply chain applications and not surprisingly the cloud is at the center of their plans. Oracle asserted that the market for supply chain applications on the cloud would grow from $1.8 billion in 2013 to $4.4 billion in 2018, which is a very significant 19% CAGR.

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Topics: Labeling, Oracle

Thoughts from the Oracle Modern Supply Chain Experience

Posted by Ken Allen on February 8, 2016

I had the wonderful opportunity to be part of the Oracle Modern Supply Chain Experience last week, located in beautiful San Jose, California. Apart from escaping the brutal New England winter for a week, the event opened my eyes to the amount of energy and passion towards supply chain methodologies, technologies, and solutions.

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Topics: Supply Chain, Oracle

Why is it so hard to stop counterfeit auto parts?

Posted by Jessica Plourde Hutter on February 5, 2016

At a time when auto manufacturers are working hard on new technology to improve auto safety — such as crash warning systems and automatic braking — they and their customers face a growing threat. Counterfeit auto components are still finding their way into the global supply chain, and the improved quality of these parts is making detection more difficult than ever.

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Topics: Automotive

Cost savings for managing and deploying barcode labeling

Posted by Maureen Perroni on February 4, 2016

The most substantial benefit in implementing an Enterprise Labeling Solution is the cost savings companies can achieve by not duplicating efforts across the globe. Using an Enterprise Labeling Solution allows a centralized approach with the ability to allow for localized autonomy as appropriate. 

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Topics: Labeling

Why is UDI labeling so important? [Video]

Posted by Jon Jagelsky on February 3, 2016

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The medical device industry has grown rapidly in recent years, and may soon outpace pharmaceuticals. For this reason, the FDA is in the process of implementing UDI regulations to improve device safety.

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Topics: UDI, Medical Devices

RoHS exemptions may expire in July

Posted by Scott Vigneault on February 1, 2016

Adopted in 2003, the Restriction of Hazardous Substances (RoHS) Directive has prohibited the use of six different hazardous substances in electronics manufacturing since it took effect in Europe in 2006. 

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Topics: RoHS

Hear about this year's Top 5 Trends in Enterprise Labeling

Posted by Maureen Perroni on January 29, 2016
Sign up for Loftware's live webinar to find out how to stay on top of the rapidly changing trends in the field of barcode labeling. 
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Topics: Labeling

Advantages of business users managing label design

Posted by Maureen Perroni on January 28, 2016

Business users are the closest to the labeling process and are on the frontlines, interacting with customers and managing the business’ labeling requirements.

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Topics: Labeling

Geopolitics will affect supply chains in 2016 [Video]

Posted by Maureen Perroni on January 27, 2016

As businesses grow their global supply chains, they have to focus on maintaining efficiency in the face of increased complexity. This year, global politics will pose an additional challenge.

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Topics: Labeling

FDA clarifies UDI rules for convenience kits

Posted by Scott Vigneault on January 26, 2016

We're in the midsts of the U.S. Food and Drug Administration's rollout of the Unique Device Identification (UDI) system. Beginning in September 2014 and continuing through 2020, medical device manufacturers will be required to add UDI labels to their products. At the outset, only pacemakers and heart valves were affected by the FDA's rules, but last September any implantable life-sustaining device was added into the fold.

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Topics: UDI

Reliable barcodes needed for shifting supply chain needs

Posted by Maureen Perroni on January 22, 2016

Manufacturing supply chains are changing. Once upon a time, these were largely linear creations, static in nature and generally located in one country. In today's global economy, supply chains are larger and more complex than ever, and face new challenges from rapidly growing consumer demand.

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Topics: Supply Chain, Labeling

Which types of applications are companies integrating with labeling?

Posted by Maureen Perroni on January 21, 2016

There is a wide range of different enterprise applications and data repositories that could be integrated with labeling. Ultimately, business systems simply reflect the data that needs to appear on the label. 

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Topics: Labeling

 

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