Department OF Defence - Imprint Enterprises - Since 1975 https://imprint-e.com Barcode Experts for Your Business And Industry Needs. Fri, 27 Mar 2020 17:26:44 +0000 en-US hourly 1 https://imprint-e.com/wp-content/uploads/2020/08/cropped-IMPRINT-ENTERPRISES-Logo100-SQ-32x32.png Department OF Defence - Imprint Enterprises - Since 1975 https://imprint-e.com 32 32 The Importance of Understanding UDI Barcode Labeling https://imprint-e.com/the-importance-of-understanding-udi-barcode-labeling/?utm_source=rss&utm_medium=rss&utm_campaign=the-importance-of-understanding-udi-barcode-labeling https://imprint-e.com/the-importance-of-understanding-udi-barcode-labeling/#respond Mon, 09 Mar 2020 13:27:40 +0000 https://imprint-e.com/?p=293367

The US Food and Drug Administration (FDA) requires using a unique device identifier (UDI) on barcode labels.  These labels must be readable by man and machine (scanners).  If the labels are not done to specific standards, your company is liable for more than just fines and chargebacks.  Private label distributors are susceptible to the possibility of a legal exposure.

Proper barcode labeling tracks materials from manufacturing, through distribution, to the end user.  This can impact patient safety and the tracking of accountability.  It is crucial to your company to understand UDI requirements on a barcode label and manage compliance labeling.

How much are those pharmaceutical and healthcare contracts worth to your company?  How do you ensure that every UDI requirement is met?

Your company is liable for more than just fines and chargebacks.  Private label distributors are susceptible to the possibility of a legal exposure.

UDI Requirements

Device labelers are required to include a UDI on devices and packages, submitting that device information to the Global Unique Device Identification Database (GUDID).  If your company applies labels to devices or cause the label of a device to be modified for commercial distribution, then it is critical for your company to adhere to UDI requirements.

Barcode labeling requirements include:

  • Brand name
  • Description
  • Catalog number
  • Size
  • Storage and handling
  • Device identifier
  • Product identifier
    • Lot or batch number
    • Serial number
    • Expiration date
    • Date of manufacturing
    • Distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.
  • Labeler name & physical address
  • Customer contact information

All labels must be readable in plain text, as well as machine readable with scanning using AIDC (automatic identification and data capture) technology.

As a device labeler, or the manufacturing company, there is the added legal exposure to meeting UDI requirements.  Legal definitions can be murky and are often confusing.  In an ERG Report released in May 2012 (page 3-2), they defined affected labeler entities to include:

  • Manufacturers
  • Relabelers and Repackagers
  • Reprocessors
  • Specification Developers (no manufacturing)

Further amendments have not changed the affected labeling entities.

Some of the general component requirements can include:

  • NSN/NATO stock number
  • CAGE code
  • Part number (PN or P/N)
  • Item description or nomenclature (as specified on contract)
  • Quantity and UI
  • Contract number or purchase order number
  • Military preservation method and date of unit preservation (if applicable)
  • Shelf-life (if applicable)
  • Serial number, preceded by SER NO
  • HAZMAT (if applicable)

Compliance Labeling

With barcode labels having to comply with ISO/IEC 15415 or ISO/IEC 15416, having a quality barcode label machine to monitor quality control for you can save you time, money, and legal hassles.

How are you checking the quality of the barcode labels you print?  By verifying the first few prints, the middle of the prints, and the last few prints?  How many barcode labels are going unchecked?

Obtain a barcode labeling machine with compliance labeling.

You can program the machine to assign a letter grade of A through F for ANSI or assign a numerical score of 4 through 0 for ISO.  The system is even designed to generate a report that you can send to your customer, providing proof of compliance labeling.

Integrated Verification Technology

A top-quality barcode label machine has an integrated verification technology system for printing 1D and 2D barcode labels that are in compliance with UDI requirements.  Each label is verified upon printing, voiding out bad labels and printing a new one that adheres to the standards set.

You can manage the label machine individually with its built-in touchscreen interface or through an intelligence software system to manage more than one at a time, at the same time.  The printing technology can also help to reduce smearing of labels, all the way down to the precise +/-0.2 mm labels.

Globally Certified

A top-quality barcode labeling machine should be designed with top global standards in mind.  It should be globally certified while also adhering to ISO and ANSI barcode labeling standards.  You should be able to modify the grading standard to make it stricter than ISO or ANSI, enhancing the quality of your barcode labels.

The Honeywell PX940 is an investment that takes the guess work out of barcode label specifications.

Don’t put your business relationship in jeopardy with bad barcode labels that could put you at a legal risk.  The PX940 will help you by providing the quality control measures that the FDA requires.  Pharmaceuticals and Healthcare can mean life or death, and so can your labels.

Bad barcode labels can result in delayed payments, fines and bad business relationships.  And in the case of UDI compliance labeling, it can mean big legal headaches.

Don’t risk your business relations and contracts.

Let the PX940 do the barcode label work for you.

Contact us today to talk about getting your PX940.

The post The Importance of Understanding UDI Barcode Labeling first appeared on Imprint Enterprises - Since 1975.

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The Importance of Vertical Verification for DOD Contracts https://imprint-e.com/the-importance-of-vertical-verification-for-dod-contracts/?utm_source=rss&utm_medium=rss&utm_campaign=the-importance-of-vertical-verification-for-dod-contracts https://imprint-e.com/the-importance-of-vertical-verification-for-dod-contracts/#respond Wed, 04 Mar 2020 13:20:51 +0000 https://imprint-e.com/?p=293307

Obtaining a contract with the Department of Defense (DOD) can be a long, tedious process, ensuring every t is crossed and every i is dotted.  Once you obtain that contract, why put all that effort and hard work into jeopardy with a bad barcode label?

The DOD requires specific unique identification (UID) markings on everything. 

These labels help with item management and accountability from manufacturing through the entire supply chain.  A bad barcode can delay critical missions and cause misplaced shipments. 

The DOD requires specific unique identification (UID) markings on everything because a bad barcode can delay critical missions and cause misplaced shipments.

Those delays and misplacements can result in delayed payments, major fines, lost contracts, and bad business relationships.  All that work put into obtaining the contract gets flushed down the drain.

Don’t let that happen to your company.  Understanding the UID requirements and having a top-quality barcode label machine saves time and money, ensuring compliance labeling is met.  Quality control is a major topic issue with the DOD.  How is your quality control?

UID Requirements

The DOD requires UID labels on tangible items, using specific standards and specifications.  These labels assist the DOD with seeing the value of the items, controlling the use of the items, and evaluate performance of those items.  With each barcode label needing to be 2D, and each line of information consisting of up to 50 characters each, there is a lot of room for error.

Some of the general component requirements can include:

  • NSN/NATO stock number
  • CAGE code
  • Part number (PN or P/N)
  • Item description or nomenclature (as specified on contract)
  • Quantity and UI
  • Contract number or purchase order number
  • Military preservation method and date of unit preservation (if applicable)
  • Shelf-life (if applicable)
  • Serial number, preceded by SER NO
  • HAZMAT (if applicable)

Compliance Labeling

With barcode label symbology having to comply with ISO/IEC 16388, having a quality barcode label machine to monitor quality control for you can save you time and money.  How are you checking the quality of the barcode labels you print?  By verifying the first few prints, the middle of the prints, and the last few prints?  How many barcode labels are going unchecked?

Quality Control

What would it mean to your business if your barcode label machine could check every single label, applying a 0 through 4 grade as per ISO standards? 

With the Honeywell PX940, you can program the machine to not only adhere to ISO grading standards but also compile a digital report to send to your customer showing the grade of every single barcode label.

Integrated Verification Technology

A top quality barcode label machine has an integrated verification technology systems for printing 2D barcode labels that are in compliance with ANSI MH10.8.1 and ISO/IEC 15438.  Each label is verified upon printing, voiding out bad labels and printing a new one that adheres to the standards set.

You can manage the label machine individually with its built-in touchscreen interface or through an intelligence software system to manage more than one at a time, at the same time.  The printing technology can also help to reduce smearing of labels. 

These technological advancements provide you with security in knowing that your barcode labels will be of top quality.

The Honeywell PX940 is an investment that takes the guess work out of barcode label specifications.

Don’t put your business relationship into jeopardy with bad barcode labels.The PX940 will help you by providing the quality control measures that the DOD requires.With UID barcode labels needing to be 2D, each line of information ranging up to 50 characters, there is a lot that could go wrong if not properly monitored.

The Honeywell PX940 monitors quality for you, applying ISO standard grades to every label, voiding bad ones for you.

The barcode labels go onto supplies that support critical missions and ensure timely delivery.Contracts with the DOD tend to be large which can grossly affect your own profit statements and future business relationships.

Don’t risk your business relations and contracts.

Let the PX940 do the barcode label work for you.

Contact us today to talk about getting your PX940.

The post The Importance of Vertical Verification for DOD Contracts first appeared on Imprint Enterprises - Since 1975.

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How To Stop Fines And Eliminate Chargebacks https://imprint-e.com/how-to-stop-fines-and-eliminate-chargebacks/?utm_source=rss&utm_medium=rss&utm_campaign=how-to-stop-fines-and-eliminate-chargebacks https://imprint-e.com/how-to-stop-fines-and-eliminate-chargebacks/#respond Thu, 27 Feb 2020 13:43:47 +0000 https://imprint-e.com/?p=293264

The barcode label is the backbone of a shipment.  Your company works hard to ensure top quality of product.  The barcode label is just as important.

Have you ever experienced chargebacks or fines due to barcode labeling problems with your shipments?  How are you checking the quality of your barcode labels?  If you are only looking at the first, middle, and last of the barcode labels being printed, how many are you not checking?  How much time would it take you to check every single label?

Verification before shipping can save time, money, and ultimately your business relationships!

A barcode label tells the receiver just what it is that they are receiving.  If the barcode label cannot be read, why would the company accept it?  Would you accept a large shipment not knowing what is in it?

When a shipment is rejected because of defunct labels, the company rejecting the order will often demand the return of their money and tack on fees to that.  You can avoid all that, saving money and wasted manhours dealing with shipment returns over subpar barcode labels.

You need a barcode label machine that has an integrated verification technology to check and grade every label as it is being printed.  Yes, every label.  Finding a top-quality machine that can check every label means that you no longer have to individually verify the scannability of random labels.  Preferably a top of the line barcode label printing machine is a globally certified product and adheres to ISO and ANSI standards.

Avoid misreads and no-reads with compliance labeling, with precision printing up to +/-0.2 mm (0.0079 in).  Consider what it would do for your business and customer relations if you could even send a quality grading report to the customer, assuring them that every barcode label is readable to top standards upon leaving your facility.  What would it take to create happy customers with easy traceability that is above and beyond their industry standards?

LABEL QUALITY = MONEY

On average, there can be 6 incidents per month where customers cannot read the barcode labels on a shipment they received.  The customer will randomly select a label to read.  If the barcode label is bad, the customer can reject the entire shipment, causing you to possibly pay a chargeback and added fees.  With the potential of a chargeback being as much as $200,000, added fees may be up to $3,000 for one delivery.

How much is that affecting your profits?  How many man hours were spent getting that shipment out the door?  How much did it cost you to get the shipment to the customer?  Add to that how much it can cost to correct the problem at the customers end (if they even keep the shipment) and it could cost you the future of that business relationship.

If you are checking the barcode labels at the beginning, middle, and end of printing, you are basically rolling the dice and crossing your fingers.  A proper barcode labeling machine can deliver peace of mind by producing labels that are of top quality, saving you money in the long run.

INTEGRATED VERIFICATION TECHNOLOGY

Do you currently have the capability of an integrated verification technology system for 1D and 2D barcodes?  A barcode label machine that does has the ability to print barcode labels and verify the integrity of the labels at the same time.  This technology system will instantly notify you of failing labels, voiding them for you and printing a new one to replace the voided one.

When the barcode label machine has a touchscreen interface system installed on it, it becomes easier to use.  You can manage the machine individually or through intelligence software to manage more than one at a time, at the same time.  The printing technology can also help to reduce smearing of labels.  These technological advancements provide you with security in knowing that your barcode labels will be of top quality.

Compliance Labeling

Your customers may have specific standards they have to adhere to for multiple reasons.  Obtain a barcode labeling machine with compliance labeling.  You can program the machine to assign a letter grade of A through F for ANSI or assign a numerical score of 4 through 0 for ISO.  The system is even designed to generate a report that you can send to your customer, providing proof of compliance labeling.

Verification for Verticals

Your customers will most likely require verification for verticals.  Spot checking labels with a barcode scanner does not provide accuracy in verification.  It will only tell you if that scanner can read a specific label.  When a barcode is scanned by a different scanner, it may not read at all.  Verification for vertical standards ensure that barcodes can be read regardless of the scanning equipment used.

Globally Certified

A top-quality barcode labeling machine should be designed with top standards in mind.  It should be globally certified and adhere to ISO and ANSI barcode labeling standards.  You should also be able to modify the grading standard to make it stricter than ISO or ANSI.  This increases your quality of barcode labels.

CREATE HAPPY CUSTOMERS

Each of your clients may have different standards that they want you to adhere to.  Create happy customers and lasting relationships by understanding and easily conforming to their industry standards.  From your facility to theirs, top quality barcode labels allow your customers to easily read what something is and track items for possible recalls.

DOD / UID

The Department of Defense (DOD) requires unique identification (UID) markings on everything.  This provides for item management and accountability throughout the entire supply chain.  The DOD uses a Military Shipment Label with linear barcodes on outer containers.  Bad barcodes can delay critical missions.

Pharmaceuticals and Healthcare / UDI

The US Food & Drug Administration (FDA) requires a unique device identifier (UDI) on every label that is readable by man and machine, from manufacturing through distribution and on to patient use.  These labels help manage patient safety.

Retail Supply Chain

From manufacturer to customer, a readable barcode eases transportation and logistics.  Each barcode is readable no matter what device is reading it.  Employees can easily scan the material to see where it goes in the store without having to open items to figure out what it is.

Automotive

The automotive industry typically uses 2D barcode technology for fast and accurate shipping.  These barcodes can also help manage parts to ease the stress of a recall by creating traceability.

THE HONEYWELL PX940 IS MORE THAN JUST A BARCODE LABEL PRINTER… IT IS AN INVESTMENT THAT PAYS DIVIDENDS FOR YEARS TO COME.

The Honeywell PX940 can provide annual cost savings as high as $14,825.  The barcode labeling machine grades every label, reducing the amount of man hours spent spend checking labels random labels and hoping for the best on the rest of them.

The Honeywell PX940 takes the guess work out of making sure every customer’s labeling requirements are met with its easy integrated verification technology and user interface systems.  From military customers to pharmaceutical and medical devices, the computer system is user friendly to allow easy customization.

Ease your customers minds by sending them reports of the graded labels.Satisfy your customers while saving yourself money in the process.Happy customers mean a healthy revenue.

Let the PX940 do the barcode label work for you.

Contact us today to schedule a demo or to discuss your specific needs.

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