Navigation

X
You've just added this product to the cart:

Drug Supply Chain Security Act (DSCSA) Mandate

Posted October 2, 2017

healthcare-2dWhat you need to know?

On November 27, 2013, Congress enacted the Drug Quality and Security Act (DQSA), which includes the Drug Supply Chain Security Act (DSCSA). The DSCSA outlines steps to build an electronic system to identify, track and trace certain prescription drugs as they are distributed in the United States. This legislation was enacted in order to transform the pharmaceutical supply chain through serialization and improve patient safety.

Manufacturers, wholesalers, re-packagers and pharmacies have been required to implement lot-level management since 2015. Starting in November 2017, phase II of the DSCSA implementation requires manufacturers and re-packagers to serialize packages of drug products using a GS1 product identifier (either GTIN or NDC), serial number, lot number and expiration date, and embed this information into a 2D Datamatrix barcode. In November 2019, wholesalers must accept only serialized products and must verify unique product identifiers. By November 2020, pharmacists must meet the same requirements. Lastly, by November 2023, all information will be required to be made available that would allow supply chain partners to trace the ownership back to the initial manufacturer or re-packager.

What does a DSCSA solution do?

Our DSCSA hardware and software solution is focused on developing a traceability solution that incorporates transaction management, repository of historical snapshots of data for retrieval, and detects exceptions and provides easy to use visibility to traceability data in a matter of seconds.

What are the benefits of DSCSA?

Besides being in compliance, patients and supply chain companies are able to take advantage of the benefits of DSCSA, such as:

  • Improved patient safety and care
  • Compliance with serialization requirements helps move the industry ahead with better traceability and accountability for the origin, chain of custody, delivery, and availability of authentic, original prescription drugs
  • Improved accessibility to patients for the drugs they need and assurance that they are exactly the drugs prescribed by their physicians
  • Reduction of counterfeit drugs by having serialized identifiers
  • Maintaining profits for the industry providers against counterfeit products
  • Enables quick and accurate recalls of drugs, if needed
  • Increased efficiency throughout the supply chain by optimizing inventory tracking through serialization

What do I need to be in compliance?

Converting manufacturing lines from lot-based to unit-based serialization represents an investment in software and hardware. Barcode scanners and barcode label printers are a necessity to print and scan a GS1 2D Datamatrix barcode label. Wireless networking is an option for manufacturers looking to future-proof their operations. While all facilities present different challenges, service providers like Barcodes, Inc. can provide a consultation to ensure all the technology is identified and implemented in accordance to compliance regulations.

While the deadline remains the same, the FDA has issued a one year reprieve, meaning that the agency will not take action against manufacturers who do not affix or imprint the product identifier to their packages until after November 26, 2018.

To learn more about the DSCSA drug tracing mandate or to get a free consultation on a drug tracing hardware and software solution, reach out to one of our Barcodes, Inc. representatives.

BarTender: Labeling for Every Industry and Regulation

Posted September 28, 2017

bartender-greyBarTender Software by Seagull Scientific enables organizations around the world to improve safety, security, efficiency, and compliance by helping create and automate the printing and control of labels, barcodes, RFID tags, plastic cards, and much more.

Some of the world’s largest companies and hundreds of thousands of small businesses rely on the BarTender software because it has labeling software for every industry and regulation.

A few of those industries and regulations include:

  • BarTender Software for Chemical Labeling: BarTender software is already solving the labeling challenges of chemical facilities around the world as it is an integral component of the GHS compliance labeling strategy of these chemical facilities, from ICIS top 10 manufacturers to small, regional operations.
  • BarTender Software for Food Labeling: BarTender barcode and label software is an integral component of the compliance, traceability and supply chain interoperability labeling strategies of food producers, processors, logistics providers and manufacturers around the world.
  • BarTender Software for Labeling and Marking Medical Devices: Built to help meet security demands of UDI, BarTender provides full audit trail capabilities throughout the entire labeling process. BarTender is scalable to any system requirement and is adaptable to the entire spectrum of AIDC technologies.
  • BarTender Software for Pharmaceutical Labeling: BarTender is at the heart of FDA-validated pharmaceutical manufacturing installations around the world. It delivers secure, auditable barcode and RFID labeling, all backed by industry expertise.
  • BarTender Software for Supply Chain: BarTender can help you accelerate your value chain transformation, providing integrated business planning and interoperability while offering ease of deployment and legendary technical support while being backed by industry expertise. BarTender enables compliance with the expanded security requirements of the labeling processes in regulated environments.
  • BarTender Software for EU Food Allergen (FIC) Labeling: The BarTender EU Allergen Label template is completely configurable. Automates emphasis and formatting of allergens in your ingredient list. An editable list of allergens allows easy modifications should the regulation be updated or you need to comply with other, similar, regulations that may be enacted.

Electronic Logging Device (ELD) Mandate

Posted September 22, 2017

eldWhat you need to know?

In 2012, the United States Congress enacted the “Moving Ahead for Progress in the 21st Century” bill, which included a provision requiring the FMCSA to develop a rule mandating the use of Electronic Logging Devices (ELDs). The purpose of the ELD was to electronically record a driver’s Record of Duty Status (RODS), which replaces the paper log book that drivers use to record their compliance with Hours of Service (HOS) requirements. In December 2015, the Federal Motor Carrier Safety Administration (FMCSA) published the final electronic logging device rule, or ELD Mandate. In accordance with the mandate, fleets have until December 2017 to implement certified ELDs to record HOS. Additionally, fleets that are already equipped with ELD technology will have until December 2019 to ensure compliance with the published specifications.

What does an ELD do?

ELDs installed in motor vehicles can monitor and record a whole host of data about the vehicle and its driver that go beyond RODS – from Driver Vehicle Inspection Reports (DVIR) to driver behavior reporting on speeding, idling, and hard braking. Many systems are capable of integrating map and route optimization solutions as well, which can help drivers navigate through the best routes on any given day.

What are the benefits of ELD?

Besides being in compliance and avoiding heavy fees, many fleets are already seeing the benefits of ELDs, such as:

  • Saves the drive time by reducing paperwork
  • Keeps a dispatcher updated on a driver’s status, while letting them plan for loads better in light of HOS compliance needs
  • Reduces the hassle of keeping a paper
  • Tracks a driver’s HOS electronically
  • Ensures drive segments are capture through being “integrally synchronized” with a truck’s engine
  • Synchronizes driver with fleet manager by passing data to a system where one can see e-logs in a near real-time basis
  • Save money by reducing fuel costs

Can I use rugged smartphones and tablets instead?

Knowing that there is a cost burden associated with adopting new technology, the FMCSA has authorized the use of rugged handhelds, smartphones, and tablets as the system as a whole meets ELD requirements, including a hardwired connection to the truck’s engine. This helps address the start-up costs associated with some of the HOS compliance systems. Furthermore, most truck drivers are already using rugged devices as part of their other operations, such as direct store delivery, signature capture, route optimization, and inventory management. They also allow the drivers the flexibility to choose from a wide range of mobile devices that they are comfortable using.

What are some mobile device options?

While there are hundreds of devices to choose from, here are some of the newest technologies that are ideal for the on-the-go driver:

To learn more about the ELD Mandate or to get a free consultation on an ELD hardware and software solution, reach out to one of our Barcodes, Inc. representatives.

The BarTender Print Portal App

Posted September 20, 2017

bartender-phoneMake professional label printing easy and flexible with the BarTender Print Portal App. With the powerful and secure Bartender by Seagull Scientific you’ll be able to create and automate labels, barcodes, RFID labels, plastic cards, and more.

Designed for use on either an iOS or Android device; the BarTender Print Portal App works with the BarTender Enterprise Automation Edition to let you easily choose label design, complete print-time data forms, and launch print jobs to any printer on the internet, all with strong and reliable security. Just download the app to either your smartphone or tablet and start printing.

Enterprise Automation Edition users can easily print directly from the Print Portal App to any connected printer:

  • Print to Bluetooth or IP printers directly from your Android device
  • Print to IP printers directly from your iOS device
  • Add/manipulate data in real time through in-app BarTender data entry forms
  • Automatically authenticate with a Print Portal site and browse to a specific root folder
  • BarTender security controls monitor access and permissions to labels and documents

bartender-1 bartender-2 bartender-3 bartender-4

 

Download the free App below. (Requires Enterprise Automation Edition, Contact us at Barcodes, Inc. to purchase.)

app-store-badge google-play-badge-128x128

Zebra Printing Supplies

Posted September 13, 2017

lbelsWhen it comes to consumables there are no shortage of options, but each and everyone has their benefits when it comes to maintaining your printer. Printing supplies can impact everything from the printhead lifespan to the printer’s operational efficiency. So when it comes to selecting labels, ribbons, or wristbands it is an important decision. Zebra Technologies can help, being one of the largest thermal label convertors in North America, with the expertise in converting thermal media. With four U.S. converting locations Zebra offers manufacturing redundancies resulting in quick delivery and minimal interruptions. Zebra will only use inks, varnishes, tools and equipment that meet the requirements of thermal materials.

Continue reading »

The Rugged Smartphone Market is Expanding into the Forefront of the Mobility

Posted September 5, 2017

In a world constantly searching for opportunities to stay mobilized, we are increasingly seeing every industry equipping their work force with rugged smartphones and scanner sleds. This gives the user the ability to scan and track on the go in addition to processing credit card payments in the field. Rugged smartphones and sleds have been emerging into the marketplace to help companies stay more productive away from the desk and also decrease high capital equipment costs. While there are many options on the market today, this sector is expected to see a 2-3% growth in the next few years with many new hardware and software products emerging.

 mobility-1mobility-2

 

 

 

 

 

 

 

 

 

 

 

Key benefits of using a rugged smartphone for your business:

  • A slimmer, thinner, and lighter form factor than traditional laptops and other peripherals which can easily fit in a pocket, purse, or bag.
  • No need for an additional piece of equipment as this fits directly over your iPhone or Android
  • Rugged sleds can increase durability of your device in harsh outdoor environments and also indoor facilities prone to dust and moisture.
  • Stay connected in the field using cell service to transmit data quickly when away from the office

Call one of our representatives for mobility solutions and pricing assistance.

AutoCube 8200: Honeywell’s Newest Product for Volume Shippers

Posted August 30, 2017

stand-8200Capturing dimensions can be a very manual process. The new Honeywell: AutoCube 8200 takes a 3D picture of the package, captures the dimensions prior to shipping and populates those fields into the carrier’s application. This small digital camera has a compact design that can be mounted on a pole which can be placed onto existing scales. Its ability to take instant measurements in any orientations speeds up workflow to be able to ship more packages and reduce labor costs.

Benefits:

  • Increase accuracy
  • User productivity
  • Reducing shipping charge backs
  • Optimizing storage space, work flow, and planning

This fixed dimensioning system with its ability to quickly and effectively measure objects in any orientation makes it a great add-on for warehouses and shipping stations.

For availability, contact us at Barcodes Inc.

8200

MIT Researchers Develop RFly, an Inventory Management Drone

Posted August 25, 2017

MIT researchers have developed a system that will allow small drones to read RFID tags from up to ten meters away, as well as identify the tags locations with an average error of about 19 centimeters. These researchers believe that this system could be used in large scale warehouses for both monitoring, to help prevent inventory mismatches, and to find the location of items to make it easier for employees to quickly meet customer requests. Safety won’t be an issue as these drones will be small and lightweight equipped with plastic rotors.

This will help many businesses as each year billions of dollars are lost all because of mismatches in inventory. Even the U.S. Army has had the problem of losing track of supplies.

“Between 2003 and 2011, the U.S. Army lost track of $5.8 billion of supplies among its warehouses,” says Fadel Adib, the Sony Corporation Career Development Assistant Professor of Media Arts and Sciences, whose group at the MIT Media Lab developed the new system. “In 2016, the U.S. National Retail Federation reported that shrinkage – loss of items in retail stores – averaged around $45.2 billion annually. By enabling drones to find and localize items and equipment, this research will provide a fundamental technological advancement for solving these problems.”

Watch how the system would work below.

Interested in learning more? Read the full article here news.mit.edu.

Upgrading Firmware on the Honeywell 8670 Bluetooth Ring Scanner

Posted August 18, 2017

To upgrade firmware on a Honeywell 8670 Wireless Ring Scanner, the scanner must be connected to either of the below:

  • Honeywell Access Point (HAP) – AP-010BT-07N /  AP-100BT-07N
  • Honeywell Charge and Communication Base (CCB) – CCB01

 

Once connected, fire up EZConfig – a free Honeywell barcode scanner configuration utility.  The Honeywell 8670 will not be listed as a connected device in EZConfig but the base/access point will. If it’s connected to the CCB/Access Point the firmware will find its way to the scanner.

  • Make sure the configuration is set to Bluetooth Serial Profile (PAPSPP).
  • Select “Update Firmware”
  • Select “Choose File” then pick your firmware file that you saved previously on your hard drive.  You can get the latest firmware files from the Honeywell website.
  • Select “Update Device”

Easy!

honeywell-scanning

Zebra’s 2017 Manufacturing Vision Study

Posted August 8, 2017

zebra-studyZebra Technologies commission a global study to analyze trends and challenges that impact manufacturing companies. The survey asked 1,100 executives from automotive, high tech, food, beverage, tobacco, and pharmaceutical companies for their insights on adopting technology on the plant floor to increase their competitive position. The study includes the benefits of having IIoT, RFID, and Asset Management on a plant floor.  To read more about the results of the study click the link below.

 

2017 Vision Study

 

For further information visit www.zebra.com/manufacturing

« Newer PostsOlder Posts »